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A Dose-escalating Clinical Trial With KH176

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544217
Recruitment Status : Completed
First Posted : September 9, 2015
Results First Posted : November 12, 2020
Last Update Posted : October 18, 2021
Sponsor:
Collaborator:
Drug Research Unit Ghent, Belgium
Information provided by (Responsible Party):
Khondrion BV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions MELAS
LHON
Leigh Syndrome
Mitochondrial Disease
Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation
Interventions Drug: KH176
Drug: placebo
Enrollment 32
Recruitment Details All studies were conducted at the Drug Research Unit Ghent. Participants agreed to stay in the Drug Research Unit during the first 24 h after dosing (SAD) and during Day 8 (MAD).
Pre-assignment Details  
Arm/Group Title Single Ascending Group I Single Ascending Group II Multiple Ascending Group III Multiple Ascending Group IV Multiple Ascending Group V Placebo
Hide Arm/Group Description

2 alternating groups receiving escalating single doses of active/placebo

KH176

placebo

2 alternating groups receiving escalating single doses of active/placebo

KH176

placebo

3 multiple escalating groups, receiving active/placebo

KH176

placebo

3 multiple escalating groups, receiving active/placebo

KH176

placebo

3 multiple escalating groups, receiving active/placebo

KH176

placebo

 Group receiving placebo
Period Title: Overall Study
Started 7 7 4 4 4 6
Completed 6 6 [1] 4 4 4 6
Not Completed 1 1 0 0 0 0
Reason Not Completed
Withdrawal by Subject             1             1             0             0             0             0
[1]
Two subjects prematurely withdrew from the study for non-medical reasons and were replaced.
Arm/Group Title SAD Group I SAD Group II MAD Group III MAD Group IV MAD Group V Placebo Total
Hide Arm/Group Description SAD group I: 10mg, 100mg, 800mg SAD group II: 30mg, 300mg, 2000mg MAD group III:100mg bis in die (BID) MAD group IV: 200mg BID MAD group V: 400mg BID Placebo group Total of all reporting groups
Overall Number of Baseline Participants 7 7 4 4 4 6 32
Hide Baseline Analysis Population Description
SAD:14 subjects divided in two groups of 7 subjects were included. Two subjects prematurely withdrew from the study after dosing period 2 for non-medical reasons. MAD part:18 subjects divided in 3 groups of 6 subjects were included. Two subjects prematurely withdrew from the study for non-medical reasons and were replaced.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 4 participants 4 participants 4 participants 6 participants 32 participants
30.4  (10.5) 32.0  (11.3) 40.8  (13.0) 34.5  (11.6) 44.0  (8.2) 44.7  (9.8) 40.0  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 4 participants 4 participants 4 participants 6 participants 32 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
7
 100.0%
7
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
6
 100.0%
32
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 4 participants 4 participants 4 participants 6 participants 32 participants
Hispanic or Latino
1
  14.3%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
  16.7%
3
   9.4%
Not Hispanic or Latino
6
  85.7%
7
 100.0%
4
 100.0%
3
  75.0%
4
 100.0%
5
  83.3%
29
  90.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 4 participants 4 participants 4 participants 6 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
7
 100.0%
7
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
6
 100.0%
32
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Belgium Number Analyzed 7 participants 7 participants 4 participants 4 participants 4 participants 6 participants 32 participants
7 7 4 4 4 6 32
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 7 participants 7 participants 4 participants 4 participants 4 participants 6 participants 32 participants
178.07  (6.56) 176.01  (8.11) 184.63  (2.81) 181.75  (5.25) 175.70  (3.18) 175.55  (8.25) 184.0  (4.0)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 7 participants 7 participants 4 participants 4 participants 4 participants 6 participants 32 participants
82.86  (10.56) 74.29  (12.61) 89.05  (11.84) 77.85  (11.96) 81.10  (4.82) 72.03  (6.06) 80.0  (8.0)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 7 participants 7 participants 4 participants 4 participants 4 participants 6 participants 32 participants
26.09  (2.51) 24.01  (4.01) 26.10  (2.74) 23.60  (3.82) 26.28  (1.67) 23.43  (1.98) 24.0  (4.0)
1.Primary Outcome
Title SAD: Change From Baseline in ECG Results by Timepoint: Corrected QT Interval According to Fridericia's Formula (QTcF)
Hide Description The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation of the corrected QT intervals the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing. QTcF is calculated as the quotient between the QT interval in milliseconds and the cube root of the RR interval in seconds, according to Fridericia's formula.
Time Frame Baseline, 1, 2, 4, 6, 8, 12, 24 hours, 7 day follow up
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Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: msec
Baseline (Pre-dose Day 1) 386.2  (17.2) 395.0  (9.8) 385.8  (14.8) 399.3  (8.3) 390.3  (14.6) 393.5  (14.2) 386.5  (10.9) 385.3  (16.8) 369.0  (14.1) 386.5  (13.2)
Change from baseline (BL)at 1h 4.0  (2.8) -2.0  (8.7) -0.3  (3.8) -3.5  (6.0) 0.8  (4.0) 0.8  (5.7) 0.3  (7.6) 28.8  (19.0) 4.5  (19.1) 5.8  (2.6)
Change from BL at 2h 0.5  (7.9) -4.0  (6.6) -1.8  (7.9) -4.8  (6.1) -4.8  (3.0) 1.5  (6.0) 7.8  (10.0) 28.5  (14.1) 2.5  (13.4) 1.8  (5.3)
Change from BL at 4h 6.5  (9.4) -2.2  (11.4) -3.8  (3.3) -4.3  (6.2) 1.0  (5.7) 3.8  (12.3) 3.3  (7.2) 26.0  (8.7) 8.5  (17.7) 0.3  (3.9)
Change from BL at 6h 6.2  (3.6) -2.7  (6.0) 4.3  (6.3) -4.0  (7.3) -1.0  (8.3) 5.8  (8.1) 5.5  (2.5) 26.0  (7.9) 8.5  (12.0) 6.0  (5.0)
Change from BL at 8h -0.8  (7.3) -7.2  (4.0) -5.5  (7.4) -1.8  (9.2) 4.3  (10.3) -1.8  (9.0) 0.8  (7.5) 23.3  (12.3) -2.5  (13.4) 0.5  (5.4)
Change from BL at 12h 1.8  (6.7) -5.2  (4.8) -1.8  (2.6) -7.3  (6.8) 0.0  (4.7) 0.0  (8.0) 8.0  (0.8) 19.3  (11.1) 5.5  (7.8) 3.3  (6.2)
Change from BL at 24h 5.3  (12.4) -7.5  (9.3) -4.0  (7.3) -4.8  (5.6) 0.3  (6.2) -4.3  (6.5) 0.3  (9.7) 11.3  (4.7) -1.0  (8.5) -3.8  (4.0)
Change from BL at FU -0.3  (12.4) 2.8  (7.9) -1.3  (10.8) 2.8  (8.0) 2.8  (13.1) 5.0  (6.1) -5.0  (3.2) 3.3  (7.6) 5.5  (10.6) 6.5  (13.0)
2.Primary Outcome
Title Pharmacodynamics of KH176
Hide Description Change from baseline in biochemistry related to Oxidative Phosphorylation (OXPHOS) (glutathione, lactate); MAD group
Time Frame Day 1, day 7
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Per protocol set
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
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MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
Mad group: Placebo
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: ratio GSH/GSSG
Ox glutathione (GSH)/Red Glutathati(GSSG) Day 1-0h 872  (532) 2083  (674) 2275  (792) 1584  (491)
GSH/GSSG Day 7-0h 919  (196) 1923  (433) 1918  (1007) 1694  (572)
GSH/GSSG Day 7-3h 779  (87) 2045  (338) 1935  (699) 1712  (465)
GSH/GSSG Day 7-6h 1040  (335) 2113  (687) 1993  (863) 1718  (542)
GSH/GSSG Day 7-12h 1361  (606) 1893  (279) 1875  (697) 1680  (657)
3.Primary Outcome
Title Relationship to Study Drug and Severity of Treatment-emergent Adverse Events
Hide Description [Not Specified]
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food MAD Group III 200mg MAD Group IV 400mg MAD Group V 800mg Placebo
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
100mg BID/Day (over 7 days)
200mg BID/Day (over 7 days)
400mg BID/Day (over 7 days)
MAD group: Placebo
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4 4 4 4 6
Measure Type: Number
Unit of Measure: TEAE
TEAE 5 2 2 5 7 1 0 28 1 1 9 6 14 17
Serious TEAE 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Not related TEAE 4 0 0 2 6 0 0 0 1 1 1 1 3 3
Unlikely related 0 2 2 3 0 0 0 0 0 0 1 1 2 1
Possibly related 1 0 0 0 1 0 0 3 0 0 7 4 9 13
Related 0 0 0 0 0 1 0 25 0 0 0 0 0 0
4.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: cells 10^6/µL
Baseline (pre-dose Day 1) 4.947  (0.488) 4.933  (0.307) 4.793  (0.455) 5.030  (0.458) 4.953  (0.247) 5.137  (0.393) 4.973  (0.141) 4.623  (0.395) 5.095  (0.120) 4.985  (0.343)
Change from BL at 24h 0.200  (0.495) 0.095  (0.260) 0.063  (0.085) 0.188  (0.153) 0.170  (0.250) 0.065  (0.197) 0.173  (0.200) 0.325  (0.185) 0.185  (0.064) 0.115  (0.208)
Change from BL at FU 0.003  (0.215) -0.013  (0.149) 0.185  (0.104) -0.052  (0.183) 0.083  (0.127) -0.147  (0.041) -0.053  (0.209) 0.125  (0.182) -0.150  (0.339) 0.050  (0.211)
5.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate (SAD Group)
Hide Description [Not Specified]
Time Frame Baseline (pre-dose Day1), 24h post dose, FU (7 days after last dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mm/hr
Baseline 2.3  (1.4) 2.8  (2.1) 1.3  (0.5) 1.8  (1.0) 2.0  (1.4) 3.0  (4.0) 7.3  (8.5) 4.0  (3.2) 5.0  (2.8) 2.5  (3.0)
Change from BL at 24h 0.5  (0.5) 0.3  (1.0) 0.0  (0.0) 1.0  (0.8) 0.0  (0.8) 0.3  (1.0) 0.3  (0.6) 3.0  (3.6) -0.5  (0.7) 1.0  (2.0)
Change from BL at FU 0.3  (1.2) 0.3  (1.5) 0.8  (1.0) 0.5  (1.7) 0.5  (1.7) 0.0  (0.0) -2.3  (6.8) 0.5  (1.0) 0.0  (0.0) 0.0  (0.0)
6.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Sedimentation Rate MAD Group
Hide Description [Not Specified]
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days after last dosing)
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Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
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MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD group: Placebo
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: mm/hr
Baseline (pre-dose Day 1) 4.0  (2.4) 3.0  (1.8) 2.0  (1.4) 2.7  (1.8)
Change from BL at Day 3 2.0  (3.5) 0.8  (0.5) 0.5  (0.6) 0.8  (1.7)
Change from BL at Day 8 4.8  (5.7) 0.8  (2.2) 2.5  (1.7) 0.3  (1.4)
Change from BL at FU 5.0  (8.2) 1.3  (1.3) 1.0  (0.8) 2.2  (3.5)
7.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit SAD Group
Hide Description Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24 h postdose, FU (7 days after last dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: %red cells to the volume of whole blood.
Baseline (pre-dose Day 1) 43.77  (3.35) 43.13  (2.79) 43.10  (3.46) 44.38  (3.28) 42.98  (1.41) 44.35  (2.88) 44.05  (3.17) 41.35  (1.68) 44.35  (2.33) 42.53  (1.50)
Change from BL at 24h 0.53  (1.28) 0.60  (2.10) 0.75  (0.91) 1.95  (1.41) 1.42  (2.12) 1.03  (2.11) 1.33  (1.80) 2.33  (1.87) 1.90  (0.28) 0.68  (1.92)
Change from BL at FU -0.43  (1.70) -0.65  (1.37) 0.85  (1.45) -0.93  (1.91) 0.10  (1.66) -2.02  (0.54) -1.15  (2.17) 0.07  (1.41) -0.65  (3.04) 0.55  (2.20)
8.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin. SAD
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: pg/cell
Baseline (pre-dose Day 1) 30.32  (1.83) 29.70  (0.98) 30.78  (1.71) 30.38  (0.49) 30.00  (1.75) 29.63  (0.68) 30.28  (1.26) 29.80  (1.16) 30.25  (1.77) 29.65  (2.13)
Change from BL at 24h - Day 1 0.08  (0.34) 0.23  (0.59) 0.17  (0.26) -0.08  (0.26) -0.15  (0.13) -0.60  (0.80) -0.25  (0.37) 0.33  (0.41) 0.25  (0.64) 0.20  (0.34)
Change from BL at FU -0.22  (0.15) 0.05  (0.46) -0.28  (0.57) -0.23  (0.51) -0.42  (0.37) -0.28  (0.21) -0.58  (0.22) 0.12  (0.39) -0.15  (0.35) -0.08  (0.15)
9.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin Concentration - SAD
Hide Description Erythrocyte mean corpuscular hemoglobin concentration (MCHC) is a measure of the average concentration of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: g/dL RBC
Baseline (pre-dose Day 1) 34.15  (0.34) 33.98  (1.01) 34.18  (0.46) 34.38  (0.84) 34.53  (0.45) 34.33  (1.07) 34.20  (0.65) 33.25  (0.71) 34.70  (0.57) 34.68  (0.99)
Change from BL at 24h - Day 1 -0.07  (0.32) 0.43  (0.42) 0.00  (0.35) -0.27  (0.39) -0.17  (0.15) -1.05  (0.87) -0.20  (0.42) 0.82  (0.29) 0.10  (0.57) 0.45  (0.68)
Change from BL at FU 0.17  (0.62) 0.47  (0.42) 0.27  (0.54) 0.18  (0.60) -0.05  (0.64) 0.30  (0.48) -0.13  (0.61) 1.00  (0.12) -0.60  (0.28) -0.20  (0.42)
10.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume - SAD
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24 h post dose, FU (7 days after last dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: fL
Baseline (pre-dose Day 1) 88.75  (5.36) 87.52  (3.71) 90.15  (5.73) 88.35  (2.88) 86.93  (4.75) 86.42  (2.83) 88.55  (4.57) 89.73  (4.24) 87.10  (6.65) 85.48  (4.36)
Change from BL at 24h 0.45  (0.85) -0.38  (1.09) 0.35  (0.37) 0.48  (0.41) 0.00  (0.08) 0.85  (0.73) -0.27  (0.21) -1.33  (0.72) 0.60  (0.28) -0.55  (0.79)
Change from BL at FU -1.10  (1.85) -1.03  (0.46) -1.68  (0.90) -0.92  (1.28) -1.25  (1.54) -1.52  (0.69) -1.45  (1.02) -2.30  (1.00) 1.10  (0.28) 0.20  (0.81)
11.Primary Outcome
Title MAD: Change From Baseline in ECG Results by Time Point: QTcF
Hide Description

The baseline ECG recording consists of a triplicate recording (3 recordings of a least 3 complexes within a 5 minute window) prior to dosing on Day 1. For the evaluation of the corrected QT intervals the average of the 3 recordings will be taken as baseline. Other ECG recordings will be singlet (one recording of at least 3 complexes) prior to dosing, or around the expected Cmax on Day 1 or 7 for the multiple-dose part.

QTcF is calculated as the quotient between the QT interval in milliseconds and the cube root of the RR interval in seconds, according to Fridericia's formula.
Time Frame Baseline, Day1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
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Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
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MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD group: Placebo
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: msec
Baseline (Pre-dose Day 1) 397.3  (18.4) 384.3  (21.7) 388.5  (4.7) 393.0  (18.8)
Change from BL at 2h - Day 1 0.5  (7.5) 5.5  (8.1) 7.3  (7.0) 1.7  (5.3)
Change from BL at 24h - Day 1 -4.3  (6.6) 0.5  (5.7) 3.3  (13.6) -4.8  (3.7)
Change from BL Day 7 at 1h - Day 7 -1.3  (10.2) -3.0  (3.3) -6.5  (8.1) -2.2  (2.7)
Change from BL Day 7 at 2h - Day 7 -3.5  (2.5) -0.3  (8.2) -0.8  (3.2) -0.3  (10.1)
Change from BL Day 7 at 4h -7.5  (4.7) -3.8  (3.5) -5.8  (7.7) 3.0  (11.2)
Change from BL Day 7 BL at 6h - Day 7 -1.8  (7.3) 2.0  (4.7) -7.3  (1.9) -0.5  (21.0)
Change from BL Day 7 at 8h - Day 7 -11.3  (3.2) -3.8  (6.9) -11.0  (5.3) 0.8  (3.9)
Change from BL Day 7 at 12h - Day 7 -4.3  (4.6) -5.0  (3.5) -10.0  (4.7) 1.7  (6.0)
Change from BL at pre-dose Day 2 -4.3  (6.6) 0.5  (5.7) 3.3  (13.6) -4.8  (3.7)
Change from BL at pre-dose Day 3 0.5  (8.6) 2.8  (6.4) 10.5  (17.2) -7.5  (6.8)
Change from BL at pre-dose Day 4 2.5  (14.6) 0.5  (13.6) 7.3  (10.2) -6.7  (8.4)
Change from BL at pre-dose Day 5 6.0  (13.3) 2.5  (7.2) 10.8  (6.7) -5.3  (7.3)
Change from BL at pre-dose Day 6 -1.3  (12.5) -1.5  (6.2) 7.8  (8.0) -8.2  (11.8)
Change from BL at pre-dose Day 7 -1.0  (11.9) 3.0  (9.5) 13.5  (8.7) -8.8  (9.2)
Change from BL at FU -2.3  (5.0) 4.0  (6.3) -0.5  (14.4) 6.7  (14.1)
12.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: cells 10^3/µL
Baseline (pre-dose Day 1) 4.435  (0.526) 4.773  (0.548) 4.313  (0.418) 4.863  (0.372) 4.395  (0.694) 4.475  (0.733) 4.853  (0.372) 5.118  (0.647) 5.815  (2.072) 5.535  (1.467)
Change from BL at 24h 0.343  (0.525) -0.057  (0.359) -0.033  (0.317) 0.160  (0.329) 0.257  (0.529) 0.160  (0.753) 0.528  (0.324) 0.655  (0.666) 0.220  (0.721) -0.280  (0.555)
Change from BL at FU 0.258  (0.309) -0.203  (0.662) 0.288  (0.211) -0.073  (0.367) 0.395  (0.617) -0.287  (0.618) 0.215  (0.266) -0.320  (0.592) -0.560  (1.202) -0.745  (1.535)
13.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 1570.0  (227.0) 1748.3  (441.1) 1655.0  (200.4) 1862.5  (548.2) 1485.0  (169.2) 1570.0  (273.1) 1550.0  (275.3) 1497.5  (707.6) 2260.0  (975.8) 1640.0  (243.2)
Change from BL at 24h -13.3  (223.4) -16.7  (347.3) -45.0  (192.8) -172.5  (227.1) -27.5  (58.0) 92.5  (225.6) 287.5  (353.7) 37.5  (159.9) -135.0  (261.6) -70.0  (177.6)
Change from BL at FU 86.7  (265.3) -45.0  (253.3) 180.0  (186.5) -92.5  (315.7) 127.5  (425.2) -32.5  (174.6) 135.0  (294.2) -7.5  (244.0) -190.0  (410.1) -27.5  (125.8)
14.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 2276.7  (551.2) 2296.7  (658.7) 2117.5  (369.2) 2365.0  (820.8) 2380.0  (679.0) 2197.5  (835.9) 2565.0  (462.6) 2360.0  (438.1) 2280.0  (169.7) 3192.5  (1523.9)
Change from BL at 24h 356.7  (336.9) 98.3  (171.2) 7.5  (196.7) 410.0  (593.0) 272.5  (419.1) 165.0  (335.5) 285.0  (155.0) 440.0  (601.5) 445.0  (459.6) -122.5  (584.3)
Change from BL at FU 205.0  (161.8) -16.7  (335.4) 90.0  (183.5) 107.5  (252.1) 255.0  (519.0) -167.5  (480.7) -12.5  (203.5) -382.5  (232.9) -205.0  (445.5) -557.5  (1326.2)
15.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit MAD Group
Hide Description Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
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Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
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MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD group: Placebo
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: % of red cells to volume of whole blood.
Baseline 39.93  (1.20) 43.40  (3.51) 45.10  (1.33) 43.30  (1.95)
Change from BL at Day 3 2.67  (1.94) 1.17  (1.69) 0.13  (0.45) 1.70  (1.91)
Change from BL at Day 8 3.30  (1.24) 1.22  (3.26) 0.10  (1.22) 1.93  (2.69)
Change from BL at FU 0.92  (1.06) -0.10  (3.26) -1.05  (0.64) -0.75  (2.32)
16.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days after last dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 115.0  (50.1) 191.7  (109.4) 110.0  (49.7) 137.5  (83.4) 112.5  (36.9) 200.0  (78.7) 245.0  (233.6) 110.0  (71.6) 650.0  (792.0) 152.5  (81.0)
Change from BL at 24h -5.0  (16.4) -50.0  (40.5) -17.5  (9.6) -22.5  (42.7) -15.0  (12.9) -37.5  (47.9) -25.0  (33.2) -25.0  (26.5) -25.0  (7.1) -30.0  (47.6)
Change from BL at FU -13.3  (16.3) -58.3  (93.5) -17.5  (25.0) -12.5  (43.5) -2.5  (18.9) -42.5  (61.3) 77.5  (201.6) -20.0  (18.3) -125.0  (205.1) -42.5  (42.7)
17.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h, FU (7 days post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: cells 10^3/µL
Baseline (pre-dose Day 1) 209.5  (45.9) 204.0  (15.7) 193.0  (31.9) 223.0  (21.6) 215.8  (64.0) 203.8  (7.0) 202.3  (54.5) 160.1  (100.8) 204.5  (67.2) 215.8  (55.6)
Change from BL at 24h 0.0  (9.7) 4.8  (6.1) 8.5  (12.4) 2.3  (12.8) 3.8  (20.3) -14.5  (29.7) 22.3  (13.5) 23.0  (22.8) 4.0  (7.1) 0.3  (9.0)
Change from BL at FU 11.8  (14.0) 22.5  (15.7) 23.8  (7.4) 8.5  (24.3) 16.3  (14.5) 7.3  (7.9) 15.8  (14.3) 21.5  (22.4) 1.0  (15.6) 16.3  (12.5)
18.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value ateach timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 23.3  (5.2) 25.0  (10.5) 15.0  (5.8) 30.0  (18.3) 15.0  (10.0) 32.5  (15.0) 20.0  (11.5) 22.5  (5.0) 65.0  (63.6) 25.0  (17.3)
Change from BL at 24h -5.0  (8.4) 0.0  (8.9) 2.5  (5.0) -7.5  (9.6) 0.0  (0.0) -5.0  (10.0) 2.5  (5.0) 5.0  (5.8) -20.0  (14.1) -2.5  (9.6)
Change from BL at FU 0.0  (12.6) -1.7  (7.5) 5.0  (5.8) -5.0  (10.0) 7.5  (9.6) -5.0  (12.9) 20.0  (21.6) 0.0  (8.2) -15.0  (21.2) -2.5  (5.0)
19.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 445.0  (78.2) 496.7  (71.7) 407.5  (79.3) 455.0  (81.9) 397.5  (133.0) 467.5  (98.8) 462.5  (147.1) 470.0  (87.6) 550.0  (70.7) 512.5  (133.5)
Change from BL at 24h 1.7  (46.7) -81.7  (54.9) 20.0  (78.3) -45.0  (19.3) 20.0  (122.7) -62.5  (185.5) -25.0  (112.4) 2.5  (56.8) -45.0  (21.2) -55.0  (70.5)
Change from BL at FU -21.7  (91.5) -78.3  (74.9) 30.0  (136.4) -70.0  (94.9) 5.0  (128.2) -42.5  (86.6) 0.0  (94.9) -47.5  (63.4) -20.0  (127.3) -110.0  (128.3)
20.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Volume. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD Placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: fL
Baseline (pre-dose Day 1) 87.00  (0.62) 89.32  (2.73) 86.43  (1.29) 89.02  (2.93)
Change from BL at Day 3 -0.05  (0.40) 0.52  (1.15) 0.55  (0.71) 0.40  (1.08)
Change from BL at Day 8 -0.10  (1.30) -0.43  (0.28) 0.32  (0.90) 0.28  (0.95)
Change from BL at FU 0.60  (0.74) -0.55  (0.73) 1.22  (1.31) 0.65  (0.77)
21.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD Placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: g/dL
Baseline (pre-dose Day 1) 13.68  (0.59) 15.23  (1.38) 15.68  (0.64) 14.82  (0.67)
Change from BL at Day 3 1.05  (0.66) 0.42  (0.74) 0.17  (0.22) 0.62  (0.50)
Change from BL at Day 8 1.35  (0.37) 0.55  (1.22) 0.27  (0.60) 0.75  (0.83)
Change from BL at FU 0.30  (0.49) -0.05  (1.11) -0.38  (0.47) -0.35  (0.63)
22.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count. MAD
Hide Description Blood samples were collected from participants at the indicated time points for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each time point are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD group: Placebo
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: cells 10^3/µL
Baseline (pre-dose Day 1) 5.463  (0.579) 4.753  (0.410) 5.378  (1.221) 4.583  (0.487)
Change from BL at Day 3 -0.435  (0.631) 0.480  (0.787) 0.895  (0.940) 0.277  (0.932)
Change from BL at Day 8 0.223  (2.237) 0.480  (0.252) 0.795  (0.178) 0.563  (0.983)
Change from BL at FU 0.060  (2.519) 0.230  (0.870) 1.340  (0.546) -0.140  (0.930)
23.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Neutrophils. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD Placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 3077.5  (569.5) 2602.5  (582.4) 2935.0  (966.6) 2483.3  (583.6)
Change from BL at Day 3 -567.5  (667.9) 350.0  (602.4) 437.5  (505.3) 81.7  (540.7)
Change from BL at Day 8 105.0  (2079.7) 312.5  (355.1) 537.5  (174.6) 261.0  (634.9)
Change from BL at FU 185.0  (2317.4) 177.5  (827.7) 1010.0  (622.7) -75.0  (532.1)
24.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Haemoglobin Concentration. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD Placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: g/dL RBC
Baseline (pre-dose Day 1) 34.28  (1.08) 35.05  (0.37) 34.75  (0.62) 34.23  (0.37)
Change from BL at Day 3 0.30  (0.22) 0.05  (0.62) 0.30  (0.39) 0.08  (0.48)
Change from BL at Day 8 0.47  (0.43) 0.25  (0.26) 0.50  (0.44) 0.17  (0.38)
Change from BL at FU -0.08  (0.33) 0.00  (0.27) 0.00  (0.65) -0.22  (0.44)
25.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 1627.5  (656.0) 1498.5  (125.1) 1750.0  (187.4) 1508.3  (317.1)
Change from BL at Day 3 87.5  (177.8) 159.0  (188.6) 390.0  (297.4) 215.0  (372.3)
Change from BL at Day 8 12.5  (378.5) 124.0  (148.8) 237.5  (208.1) 283.3  (402.6)
Change from BL at FU -55.0  (257.5) 39.0  (382.3) 262.5  (220.2) 5.0  (465.9)
26.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Mean Corpuscular Hemoglobin. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD Placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: pg/cell
Baseline (pre-dose Day 1) 29.80  (0.91) 31.33  (1.24) 30.03  (0.49) 30.47  (0.97)
Change from BL at Day 3 0.25  (0.13) 0.23  (0.39) 0.45  (0.26) 0.20  (0.25)
Change from BL at Day 8 0.40  (0.40) 0.12  (0.22) 0.57  (0.62) 0.25  (0.33)
Change from BL at FU 0.15  (0.47) -0.20  (0.08) 0.40  (0.41) 0.02  (0.25)
27.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
[Not Specified]
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: cells 10^6/µL
Baseline (pre-dose Day 1) 4.588  (0.108) 4.858  (0.380) 5.217  (0.138) 4.873  (0.360)
Change from BL at Day 3 0.313  (0.234) 0.100  (0.193) -0.017  (0.060) 0.167  (0.196)
Change from BL at Day 8 0.385  (0.139) 0.160  (0.362) -0.007  (0.144) 0.198  (0.249)
Change from BL at FU 0.075  (0.099) 0.020  (0.350) -0.192  (0.145) -0.120  (0.237)
28.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD Placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 212.5  (79.3) 183.5  (84.6) 127.5  (45.7) 141.7  (96.2)
Change from BL at Day 3 -40.0  (52.3) -31.0  (53.2) 7.5  (20.6) -28.3  (43.6)
Change from BL at Day 8 -47.5  (87.3) -28.5  (66.0) -10.0  (27.1) -22.7  (56.4)
Change from BL at FU -27.5  (131.8) 31.5  (26.5) -17.5  (27.5) -45.0  (76.4)
29.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD Placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 505.0  (44.3) 424.0  (140.9) 530.0  (134.9) 418.3  (61.5)
Change from BL at Day 3 75.0  (151.5) -11.5  (142.6) 57.5  (115.0) 1.7  (64.3)
Change from BL at Day 8 137.5  (374.6) 76.0  (95.3) 27.5  (42.7) 24.3  (53.1)
Change from BL at FU -52.5  (176.7) -21.5  (140.5) 82.5  (76.8) -43.3  (85.0)
30.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Thrombocytes. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD Placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: cells 10^3/µL
Baseline (pre-dose Day 1) 207.3  (24.6) 211.5  (41.2) 199.8  (25.6) 206.7  (48.1)
Change from BL at Day 3 15.5  (14.5) 17.5  (9.5) 27.5  (8.4) 17.3  (15.1)
Change from BL at Day 8 44.8  (37.6) 4.8  (22.3) 31.3  (13.9) 29.5  (12.5)
Change from BL at FU 63.8  (41.3) 5.5  (21.9) 33.8  (20.0) 21.7  (10.7)
31.Primary Outcome
Title Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils. MAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), Day 3, Day 8, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title MAD Group III MAD Group IV MAD Group V Placebo
Hide Arm/Group Description:
MAD group III:100mg BID
MAD group IV: 200mg BID
MAD group V: 400mg BID
MAD Placebo group
Overall Number of Participants Analyzed 4 4 4 6
Mean (Standard Deviation)
Unit of Measure: cells/µL
Baseline (pre-dose Day 1) 30.0  (8.2) 34.0  (10.8) 20.0  (11.5) 23.3  (10.3)
Change from BL at Day 3 7.5  (17.1) 8.5  (17.4) 2.5  (5.0) 3.3  (8.2)
Change from BL at Day 8 12.5  (20.6) -6.5  (17.0) 5.0  (12.9) 4.0  (14.7)
Change from BL at FU 7.5  (15.0) 1.0  (6.6) 2.5  (12.6) 5.0  (18.7)
32.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Aspartate Aminotransferase. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (pre-dose Day 1) 20.5  (5.9) 16.8  (2.7) 19.3  (4.3) 17.5  (3.8) 18.3  (9.2) 20.8  (4.4) 18.8  (6.1) 17.0  (2.9) 19.5  (2.1) 18.5  (4.8)
Change from BL at 24h -2.7  (1.2) 0.3  (2.1) -0.5  (1.3) 1.8  (3.0) -2.5  (4.7) -0.3  (1.0) -1.0  (3.3) 0.5  (2.5) -1.0  (2.8) -1.0  (2.2)
Change from BL at FU 0.3  (1.0) 3.3  (5.8) 2.8  (6.2) 4.8  (7.6) 0.3  (4.9) 0.5  (7.6) 1.3  (3.6) 1.0  (3.7) 3.5  (6.4) 0.0  (1.4)
33.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Protein. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline (pre-dose Day 1) 67.5  (4.9) 65.5  (5.2) 67.0  (4.1) 67.3  (2.2) 65.3  (5.0) 66.0  (1.8) 66.3  (3.5) 66.0  (1.4) 66.5  (2.1) 66.3  (5.4)
Change from BL at 24h 1.3  (2.7) 3.7  (3.6) 1.5  (1.0) 3.0  (2.4) 2.8  (4.0) 6.0  (1.6) 3.0  (5.0) 9.3  (4.8) 2.5  (4.9) 2.3  (4.6)
Change from BL at FU 1.5  (2.9) 3.3  (3.1) 4.0  (2.2) 1.8  (3.9) 3.3  (1.7) 0.8  (1.7) 0.0  (2.2) 4.8  (3.3) 1.0  (1.4) 2.3  (3.2)
34.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Gamma-GT. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (pre-dose Day 1) 23.5  (26.7) 19.0  (14.1) 24.0  (20.0) 23.0  (16.2) 12.0  (6.8) 17.3  (12.1) 30.0  (30.8) 21.3  (17.2) 29.0  (14.1) 13.5  (5.1)
Change from BL at 24h -0.8  (1.7) 1.2  (2.1) 0.0  (0.8) 0.8  (1.7) 0.3  (1.3) 1.3  (0.5) -0.5  (4.4) 3.8  (3.1) 0.0  (2.8) 0.8  (1.0)
Change from BL at FU -4.0  (13.8) 10.0  (16.1) -1.3  (4.5) 13.8  (18.4) 2.5  (2.4) 11.3  (20.5) -7.3  (15.6) 1.8  (2.5) 3.5  (3.5) 1.0  (0.8)
35.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (pre-dose Day 1) 62.0  (18.6) 64.0  (19.8) 66.0  (18.5) 75.0  (32.2) 66.0  (25.0) 68.3  (28.0) 53.3  (10.2) 49.0  (8.9) 54.5  (2.1) 62.3  (21.7)
Change from BL at 24h -0.2  (3.0) 1.7  (3.5) 1.0  (2.8) -1.8  (8.1) 1.0  (4.7) 3.8  (4.6) 1.3  (3.6) 6.8  (3.5) 2.0  (2.8) 0.8  (3.6)
Change from BL at FU -1.5  (9.0) 1.7  (6.3) 1.8  (3.5) -3.8  (18.2) 1.5  (3.4) -1.5  (11.3) -2.0  (5.4) 4.3  (1.5) 2.0  (2.8) -0.8  (4.9)
36.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (pre-dose Day 1) 0.927  (0.058) 0.768  (0.108) 0.903  (0.028) 0.810  (0.091) 0.838  (0.035) 0.735  (0.108) 0.918  (0.043) 0.838  (0.213) 0.935  (0.078) 0.863  (0.024)
Change from BL at 24h 0.023  (0.050) 0.067  (0.033) 0.080  (0.054) 0.053  (0.076) 0.040  (0.041) 0.115  (0.025) 0.090  (0.043) 0.075  (0.112) 0.015  (0.106) 0.038  (0.071)
Change from BL at FU -0.003  (0.048) 0.065  (0.048) 0.012  (0.039) 0.073  (0.056) 0.088  (0.068) 0.063  (0.028) -0.020  (0.096) -0.017  (0.085) -0.080  (0.071) 0.063  (0.068)
37.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Chloride. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (pre-dose Day 1) 102.7  (2.7) 104.0  (1.7) 103.8  (1.7) 104.0  (0.8) 102.3  (2.4) 103.0  (1.4) 103.3  (1.5) 103.8  (1.7) 100.5  (2.1) 101.5  (2.1)
Change from BL at 24h -0.5  (1.4) -2.5  (1.4) -1.5  (2.5) -3.5  (0.6) 0.0  (1.8) -2.8  (1.0) -1.3  (1.0) -3.5  (1.7) 2.0  (0.0) -0.5  (1.3)
Change from BL at FU -1.5  (3.5) -3.2  (2.2) -2.5  (2.1) -3.5  (1.3) -0.8  (2.2) -2.3  (2.2) -0.8  (3.5) -3.0  (0.0) 3.5  (3.5) 0.0  (2.7)
38.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Total Bilirubin. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (pre-dose Day 1) 0.82  (0.32) 0.75  (0.60) 1.03  (0.83) 0.68  (0.33) 1.18  (1.03) 0.53  (0.13) 0.63  (0.22) 0.31  (0.19) 0.45  (0.21) 1.10  (1.33)
Change from BL at 24h 0.30  (0.26) 0.12  (0.08) 0.40  (0.08) 0.38  (0.13) -0.00  (0.18) 0.28  (0.10) -0.03  (0.15) 0.31  (0.09) 0.15  (0.07) 0.27  (0.17)
Change from BL at FU 0.13  (0.42) -0.02  (0.40) 0.05  (0.13) 0.13  (0.13) -0.18  (0.33) 0.20  (0.18) 0.00  (0.29) 0.21  (0.10) 0.10  (0.14) -0.10  (0.56)
39.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Alanine Aminotransferase. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (pre-dose Day 1) 20.2  (11.3) 17.2  (6.9) 19.3  (3.2) 20.0  (10.1) 15.0  (6.9) 19.3  (6.6) 22.8  (12.8) 17.8  (6.8) 19.0  (1.4) 15.0  (5.7)
Change from BL at 24h -1.2  (2.2) -0.3  (3.2) 0.8  (2.9) -1.3  (3.5) 1.3  (1.3) -0.3  (2.8) -2.0  (3.6) 0.3  (3.9) 1.5  (2.1) 1.5  (1.0)
Change from BL at FU -1.0  (4.5) 5.7  (17.7) 2.3  (7.8) 8.3  (18.0) 1.8  (2.6) 6.0  (21.5) -2.3  (5.7) -1.0  (2.9) 7.5  (9.2) 1.8  (2.1)
40.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Creatinine Kinase. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (pre-dose Day 1) 118.2  (39.3) 78.7  (5.9) 181.8  (59.3) 78.8  (13.4) 209.3  (223.6) 82.3  (28.0) 68.5  (49.5) 89.5  (45.4) 82.5  (89.8) 81.3  (29.4)
Change from BL at 24h -34.3  (23.1) -14.0  (3.3) -51.0  (34.6) -12.8  (1.9) -97.8  (137.1) -15.5  (14.1) -14.0  (23.6) -14.8  (26.9) -31.5  (43.1) -14.8  (8.3)
Change from BL at FU 13.0  (43.7) 16.7  (35.7) -17.3  (88.6) 24.5  (39.4) -110.0  (173.1) 6.0  (7.5) 15.8  (16.9) 7.0  (61.9) 21.5  (17.7) 18.0  (31.2)
41.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Urea. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (pre-dose Day 1) 27.5  (9.3) 24.7  (4.5) 30.0  (8.4) 26.0  (7.3) 24.0  (2.4) 25.3  (4.1) 29.3  (10.6) 34.8  (7.7) 38.5  (6.4) 25.8  (5.7)
Change from BL at 24h 0.0  (3.9) 0.2  (4.4) -2.5  (5.0) -0.3  (2.5) 0.0  (2.8) -0.5  (5.2) -1.0  (4.7) -4.0  (8.6) -9.0  (1.4) -0.5  (3.3)
Change from BL at FU 1.2  (7.1) 0.5  (7.7) -0.8  (3.9) 2.3  (7.7) 0.3  (4.5) -2.3  (7.3) -0.3  (5.4) -6.8  (11.8) -8.0  (4.2) -1.5  (4.7)
42.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Sodium. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (pre-dose Day 1) 141.8  (1.0) 142.5  (1.2) 141.5  (0.6) 142.8  (1.0) 141.5  (1.7) 142.0  (0.8) 142.3  (1.3) 143.3  (1.0) 139.5  (0.7) 140.5  (1.0)
Change from BL at 24h -0.2  (1.6) -0.7  (0.8) -0.3  (2.2) -2.0  (1.4) -0.8  (2.2) -1.0  (0.8) 0.5  (0.6) -1.3  (1.0) 2.5  (2.1) 1.0  (2.6)
Change from BL at FU -0.3  (2.4) -1.8  (2.0) 0.0  (2.7) -2.3  (2.2) 0.8  (1.3) -2.0  (0.8) 0.5  (2.4) -2.8  (1.3) 4.5  (0.7) 1.8  (0.5)
43.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Potassium. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (pre-dose Day 1) 4.25  (0.18) 4.27  (0.18) 4.25  (0.13) 4.18  (0.25) 4.03  (0.19) 4.33  (0.13) 4.28  (0.32) 4.50  (0.18) 4.00  (0.00) 4.20  (0.22)
Change from BL at 24h 0.17  (0.18) 0.17  (0.21) 0.07  (0.31) 0.23  (0.33) 0.30  (0.22) -0.05  (0.26) 0.12  (0.10) -0.10  (0.16) 0.25  (0.07) 0.15  (0.34)
Change from BL at FU 0.25  (0.10) 0.10  (0.26) 0.30  (0.22) 0.20  (0.29) 0.50  (0.22) 0.10  (0.27) 0.08  (0.36) -0.05  (0.10) 0.30  (0.14) 0.33  (0.17)
44.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Phosphate. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (pre-dose Day 1) 1.042  (0.066) 0.998  (0.122) 1.120  (0.117) 1.085  (0.133) 1.023  (0.081) 0.983  (0.165) 1.088  (0.142) 1.128  (0.193) 1.410  (0.552) 1.105  (0.154)
Change from BL at 24h 0.033  (0.126) -0.045  (0.094) -0.035  (0.169) -0.133  (0.105) 0.045  (0.172) -0.060  (0.111) 0.032  (0.116) -0.090  (0.164) -0.180  (0.999) -0.015  (0.079)
Change from BL at FU -0.020  (0.116) 0.030  (0.172) -0.077  (0.126) -0.018  (0.182) 0.003  (0.046) -0.070  (0.153) -0.090  (0.121) -0.105  (0.135) -0.395  (0.205) -0.080  (0.097)
45.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Calcium (Corrected for Albumin). SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (pre-dose Day 1) 2.380  (0.073) 2.303  (0.087) 2.290  (0.114) 2.288  (0.030) 2.373  (0.116) 2.358  (0.069) 2.353  (0.102) 2.323  (0.044) 2.340  (0.000) 2.360  (0.118)
Change from BL at 24h 0.033  (0.045) 0.095  (0.066) 0.098  (0.050) 0.093  (0.028) 0.058  (0.105) 0.085  (0.059) 0.078  (0.075) 0.148  (0.055) -0.005  (0.021) 0.075  (0.088)
Change from BL at FU 0.010  (0.041) 0.062  (0.075) 0.085  (0.070) 0.073  (0.098) 0.042  (0.030) -0.032  (0.006) -0.005  (0.033) 0.090  (0.059) -0.065  (0.049) 0.055  (0.039)
46.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Uric Acid. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (pre-dose Day 1) 5.52  (0.84) 4.85  (0.84) 5.75  (0.42) 4.80  (0.37) 5.48  (0.82) 4.75  (0.79) 5.48  (1.07) 5.10  (0.96) 5.45  (0.21) 5.50  (1.41)
Change from BL at 24h -0.25  (0.40) -0.13  (0.23) -0.28  (0.25) -0.20  (0.24) -0.30  (0.12) -0.25  (0.24) -0.20  (0.32) 0.15  (0.42) -0.60  (0.28) -0.28  (0.40)
Change from BL at FU 0.28  (0.26) 0.32  (0.50) 0.22  (0.79) 0.40  (0.43) 0.35  (0.53) 0.30  (0.08) 0.18  (0.68) 0.23  (0.22) 0.40  (0.28) 0.33  (0.51)
47.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triiodothyronine (T3). SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline (pre-dose Day 1) 3.65  (0.35) 3.23  (0.12) 3.73  (0.21) 3.40  (0.22) 3.48  (0.30) 3.18  (0.17) 3.18  (0.17) 3.33  (0.19) 3.60  (0.14) 3.63  (0.41)
Change from BL at 24h -0.35  (0.28) -0.10  (0.24) -0.22  (0.17) 0.05  (0.31) -0.07  (0.10) -0.23  (0.10) -0.23  (0.36) -0.13  (0.15) -0.40  (0.00) -0.25  (0.17)
Change from BL at FU -0.30  (0.28) 0.42  (0.23) -0.23  (0.13) 0.30  (0.23) -0.13  (0.17) 0.50  (0.34) 0.05  (0.13) 0.20  (0.08) -0.30  (0.14) -0.28  (0.15)
48.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Lipase. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (pre-dose Day 1) 31.0  (8.2) 34.8  (16.2) 39.0  (9.8) 29.3  (12.7) 27.3  (7.5) 33.0  (9.2) 30.0  (8.0) 25.5  (6.2) 42.0  (14.1) 31.1  (11.8)
Change from BL at 24h -1.5  (3.1) -7.5  (18.5) -6.3  (6.8) -1.8  (2.9) 1.3  (0.5) 7.3  (16.5) -1.3  (3.4) -4.8  (5.1) -0.5  (2.1) -2.5  (5.1)
Change from BL at FU -1.0  (2.3) -1.0  (5.5) -4.5  (12.4) 8.0  (27.2) 1.5  (3.0) -5.0  (3.7) -2.0  (6.5) 9.3  (19.8) -7.0  (4.2) -2.5  (3.0)
49.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: (Fasting) Glucose. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (pre-dose Day 1) 85.0  (7.3) 86.8  (8.9) 84.8  (7.4) 88.5  (12.2) 77.8  (5.7) 86.3  (9.4) 87.0  (4.2) 95.5  (18.7) 84.0  (5.7) 78.8  (3.8)
Change from BL at 24h -1.0  (3.2) 1.2  (5.2) 2.0  (3.7) -2.0  (3.2) 7.0  (4.5) -1.0  (1.4) 0.5  (3.1) -2.3  (1.0) 4.0  (1.4) 3.3  (1.9)
Change from BL at FU -0.2  (7.0) 5.5  (6.9) -0.3  (7.7) 6.3  (6.7) 7.3  (6.2) 0.5  (5.9) -1.3  (5.4) -1.5  (1.7) 2.0  (8.5) 6.3  (3.8)
50.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Human Serum Albumin. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline (pre-dose Day 1) 46.2  (3.1) 45.0  (2.8) 45.3  (3.9) 45.0  (1.2) 45.3  (3.4) 46.0  (1.4) 44.0  (1.2) 44.3  (1.5) 44.0  (1.4) 45.8  (3.1)
Change from BL at 24h -0.3  (1.2) 1.7  (1.5) 0.3  (1.5) 2.0  (2.6) 1.5  (3.7) 3.5  (1.3) 1.5  (3.1) 5.3  (2.6) 0.5  (2.1) 0.0  (2.7)
Change from BL at FU 0.2  (1.8) 2.0  (1.4) 2.3  (1.5) 2.0  (2.8) 1.0  (1.2) 0.5  (1.3) 0.0  (0.8) 3.5  (2.1) 0.0  (0.0) 05  (1.7)
51.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Cholesterol. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (pre-dose Day 1) 176.0  (47.7) 151.0  (26.6) 146.3  (37.5) 149.0  (38.3) 146.5  (49.7) 167.5  (42.3) 212.8  (48.2) 174.5  (34.5) 200.5  (10.6) 166.5  (28.1)
Change from BL at 24h 4.8  (5.5) 12.5  (10.6) 5.3  (2.2) 5.3  (6.4) 9.5  (14.0) 19.5  (4.0) 8.3  (21.0) 25.0  (12.7) 12.5  (12.0) 5.8  (10.7)
Change from BL at FU 5.0  (20.4) 26.3  (27.2) 25.3  (5.1) 21.5  (15.5) 28.3  (17.7) 24.3  (16.7) -13.8  (33.7) 6.8  (5.4) -2.5  (41.7) 8.3  (9.3)
52.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: High Density Lipoproteins. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (pre-dose Day 1) 50.0  (11.1) 49.8  (8.4) 45.5  (11.0) 49.5  (8.9) 40.0  (4.1) 54.5  (5.5) 51.5  (9.6) 48.0  (13.3) 47.0  (17.0) 45.8  (7.3)
Change from BL at 24h -2.8  (2.4) 0.5  (3.1) 1.0  (1.2) -2.5  (2.9) -1.3  (2.1) 2.8  (2.2) -3.0  (6.0) 10.0  (7.3) 2.5  (7.8) -0.3  (1.5)
Change from BL at FU 1.8  (5.2) 4.5  (5.0) 6.3  (4.6) 3.0  (3.6) 7.3  (2.6) 2.8  (5.1) -3.0  (9.9) 8.8  (7.4) -2.0  (7.1) 1.5  (6.1)
53.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Triglycerides. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (pre-dose Day 1) 72.8  (19.0) 88.5  (62.1) 57.3  (13.0) 84.5  (46.8) 72.0  (9.6) 71.0  (33.6) 76.3  (15.7) 117.0  (99.5) 92.5  (57.3) 86.3  (20.8)
Change from BL at 24h 16.7  (7.2) 19.0  (17.3) 10.3  (3.0) 31.0  (18.1) 20.3  (16.3) 22.5  (18.4) 27.0  (9.5) -10.3  (46.7) 1.5  (29.0) 7.8  (20.2)
Change from BL at FU 16.5  (24.5) 24.5  (58.6) 30.8  (48.8) 47.3  (75.3) 12.5  (19.3) 37.5  (86.5) 37.8  (47.1) -16.5  (48.6) 43.5  (89.8) -1.8  (18.6)
54.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Low Density Lipoproteins. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (pre-dose Day 1) 111.1  (41.9) 83.5  (24.9) 88.9  (32.5) 82.5  (35.3) 92.3  (46.4) 98.7  (35.6) 145.9  (45.7) 103.1  (40.0) 134.5  (16.3) 103.5  (25.7)
Change from BL at 24h 4.5  (6.9) 8.3  (4.6) 2.9  (3.1) 1.4  (6.4) 6.4  (10.3) 12.8  (2.6) 5.7  (16.2) 16.7  (7.8) 10.0  (9.9) 4.4  (7.1)
Change from BL at FU 0.3  (19.7) 17.0  (15.6) 13.3  (10.8) 9.6  (6.9) 18.5  (16.4) 14.2  (6.2) -17.9  (35.8) 1.3  (7.7) -8.5  (30.4) 7.2  (6.8)
55.Primary Outcome
Title Change From Baseline in Chemistry Laboratory Test Results by Timepoint: Bicarbonate. SAD Group
Hide Description Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value.
Time Frame Baseline (pre-dose Day 1), 24h post dose, FU (7 days post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all subjects who have been assigned treatment and have been administered at least once with placebo or KH176.
Arm/Group Title Group I Placebo Group II Placebo SAD Group I 10mg SAD Group II 30mg SAD Group I 100mg SAD Group II 300mg SAD Group I 800mg SAD Group II 2000mg Group I Placebo + Food Group I 100mg + Food
Hide Arm/Group Description:
Placebo - single dose
Placebo - single dose
10mg KH176 - single dose
30mg KH176 - single dose
100mg KH176 - single dose
300mg KH176 - single dose
800mg KH176 - single dose
2000mg KH176 - single dose
Placebo + high calorie/high fat breakfast
100mg KH176 + high calorie/high fat breakfast
Overall Number of Participants Analyzed 6 6 4 4 4 4 4 4 2 4
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (pre-dose Day 1) 25.68  (1.38) 25.22  (0.51) 24.78  (1.09) 25.85  (0.53) 24.85  (1.21) 24.28  (0.33) 27.05  (0.91) 26.03  (1.80) 24.90  (0.71) 25.93  (0.84)
Change from BL at 24h -0.05  (1.15) 0.28  (1.31) 1.05  (1.27) 1.18  (0.90) 0.40  (0.94) 2.35  (0.70) -0.17  (0.94) 0.05  (1.55) 1.95  (0.64) 0.05  (0.39)
Change from BL at FU -1.22  (1.38) 0.97  (1.04) -0.58  (1.46) 0.95  (0.88) -0.15  (0.55) 1.65  (1.20) -2.38  (1.64) -0.20  (1.03) -0.55  (0.49) -1.23  (0.30)