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Trial record 1 of 1 for:    NCT02415439
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A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT02415439
Recruitment Status : Completed
First Posted : April 14, 2015
Results First Posted : January 5, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
ReveraGen BioPharma, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: VBP15
Drug: Placebo
Enrollment 86
Recruitment Details In the single ascending dose (SAD) study, subjects were assigned to 1 of 7 dose groups and received a single oral dose of VBP15 or placebo. The multiple ascending dose (MAD) was initiated after a review of safety data from SAD groups. In the MAD study, subjects were randomized to 1 of 4 groups to receive VBP15 or placebo once daily for 14 days
Pre-assignment Details An escalating-dose design was chosen for the SAD and MAD studies to allow increase of the dose after assessment of safety and tolerability of each preceding dose. Escalation to the next higher dose was performed using a factor of 3 for each subsequent dose until a maximum of 20 mg/kg was reached. No subject received more than 1 dose level of VBP15.
Arm/Group Title VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasted SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD VBP15- 1.0 mg/kg 14 Day MAD VBP15- 3.0 mg/kg 14 Day MAD VBP15- 9.0 mg/kg 14 Day MAD VBP15- 20 mg/kg 14 Day MAD Placebo MAD
Hide Arm/Group Description Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal. Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions. Subjects were orally administered a single dose of placebo under fasted conditions. Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions. Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions. Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions. Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions. Subjects were orally administered placebo daily for 14 days under fasted conditions.
Period Title: Overall Study
Started 6 6 6 6 6 6 6 12 6 6 6 6 8
Completed 6 6 6 6 6 6 6 12 5 6 6 6 8
Not Completed 0 0 0 0 0 0 0 0 1 0 0 0 0
Arm/Group Title VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasted SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD VBP15- 1.0 mg/kg 14 Days MAD VBP15 - 3.0 mg/kg 14 Days MAD VBP15- 9.0 mg/kg 14 Days MAD VBP15- 20.0 mg/kg 14 Days MAD Placebo MAD Total
Hide Arm/Group Description Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions Subjects were orally administered a single dose of placebo under fasted conditions Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions Subjects were orally administered placebo daily for 14 days under fasted conditions Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 6 12 6 6 6 6 8 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 6 participants 6 participants 6 participants 6 participants 8 participants 86 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
12
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
8
 100.0%
86
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 6 participants 6 participants 6 participants 6 participants 8 participants 86 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
12
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
8
 100.0%
86
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 12 participants 6 participants 6 participants 6 participants 6 participants 8 participants 86 participants
6 6 6 6 6 6 6 12 6 6 6 6 8 86
1.Primary Outcome
Title Number of Subjects With Adverse Effects After a Single Dose of VBP15
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay of 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasting SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD
Hide Arm/Group Description:
Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
Subjects were administered a single dose of placebo under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 12
Measure Type: Number
Unit of Measure: participants
2 1 1 1 0 1 0 0
2.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay of 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasted SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD
Hide Arm/Group Description:
Subjects were administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
Subjects were administered a single dose of placebo under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: (hr*ng/mL)
42  (17) 161  (16) 486  (20) 1578  (21) 3997  (55) 10139  (25) 8545  (30) 0  (0)
3.Primary Outcome
Title Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay of 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasting SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD
Hide Arm/Group Description:
Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
Subjects were administered a single dose of placebo under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: (ng/mL)
13  (13) 51  (17) 122  (33) 305  (24) 718  (43) 1817  (31) 1648  (17) 0  (0)
4.Primary Outcome
Title Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay of 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VBP15- 1.0 mg/kg 14 Days MAD VBP15- 3.0 mg/kg 14 Days MAD VBP15- 9.0 mg/kg 14 Days MAD VBP15- 20.0 mg/kg 14 Days MAD Placebo MAD
Hide Arm/Group Description:
Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally admistered placebo daily for 14 days under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 8
Measure Type: Number
Unit of Measure: participants
2 0 0 2 2
5.Primary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay of 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VBP15- 1.0 mg/kg 14 Days MAD VBP15- 3.0 mg/kg 14 Days MAD VBP15- 9.0 mg/kg 14 Days MAD VBP15- 20.0 mg/kg 14 Days MAD Placebo MAD
Hide Arm/Group Description:
Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally admistered placebo daily for 14 days under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 12
Mean (Standard Deviation)
Unit of Measure: (hr*ng/mL)
794  (22) 1494  (19) 4366  (20) 9309  (39) 0  (0)
6.Primary Outcome
Title Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15
Hide Description [Not Specified]
Time Frame Participants will be followed for the duration of hospital stay of 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VBP15- 1.0 mg/kg 14 Days MAD VBP15- 3.0 mg/kg 14 Days MAD VBP15- 9.0 mg/kg 14 Days MAD VBP15- 20.0 mg/kg 14 Days MAD Placebo MAD
Hide Arm/Group Description:
Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
Subjects were orally admistered placebo daily for 14 days under fasted conditions.
Overall Number of Participants Analyzed 6 6 6 6 8
Mean (Standard Deviation)
Unit of Measure: (ng/mL)
153  (16) 281  (37) 1082  (23) 2416  (51) 0  (0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasted SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD VBP15- 1.0 mg/kg 14 Days MAD VBP15- 3.0 mg/kg 14 Days MAD VBP15- 9.0 mg/kg 14 Days MAD VBP15- 20.0 mg/kg 14 Days MAD Placebo MAD
Hide Arm/Group Description Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions. Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal. Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. Subjects were orally administered a single dose of placebo under fasted conditions. Subjects were orally administered a dose of VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions. Subjects were orally administered a dose of VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions. Subjects were orally administered a dose of VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions. Subjects were orally administered a dose of VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions. Subjects were orally administered a dose of placebo daily for 14 days under fasted conditions.
All-Cause Mortality
VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasted SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD VBP15- 1.0 mg/kg 14 Days MAD VBP15- 3.0 mg/kg 14 Days MAD VBP15- 9.0 mg/kg 14 Days MAD VBP15- 20.0 mg/kg 14 Days MAD Placebo MAD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasted SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD VBP15- 1.0 mg/kg 14 Days MAD VBP15- 3.0 mg/kg 14 Days MAD VBP15- 9.0 mg/kg 14 Days MAD VBP15- 20.0 mg/kg 14 Days MAD Placebo MAD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/12 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VBP15- 0.1 mg/kg SAD VBP15- 0.3 mg/kg SAD VBP15- 1.0 mg/kg SAD VBP15- 3.0 mg/kg SAD VBP15- 8.0 mg/kg Fasted SAD VBP15- 8.0 mg/kg Fed SAD VBP15- 20.0 mg/kg SAD Placebo SAD VBP15- 1.0 mg/kg 14 Days MAD VBP15- 3.0 mg/kg 14 Days MAD VBP15- 9.0 mg/kg 14 Days MAD VBP15- 20.0 mg/kg 14 Days MAD Placebo MAD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      1/6 (16.67%)      1/6 (16.67%)      1/6 (16.67%)      0/6 (0.00%)      1/6 (16.67%)      0/6 (0.00%)      0/12 (0.00%)      2/6 (33.33%)      0/6 (0.00%)      0/6 (0.00%)      2/6 (33.33%)      2/8 (25.00%)    
Ear and labyrinth disorders                           
Ear Pain, Left  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Gastrointestinal disorders                           
Nausea  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Worsening of toothache-right upper molar [1]  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Vomiting  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
General disorders                           
Non-cardiac chest pain  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Investigations                           
Blood bilirubin, increased  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Elevated liver enzymes  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Elevated liver enzyme: ALT  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders                           
Pain extremity left elbow [2]  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders                           
Headache  1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0
Dizziness  0/6 (0.00%)  0 1/6 (16.67%)  2 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
Syncope  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0
[1]
Toothache
[2]
Arthralgia
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric P. Hoffman, PhD
Organization: ReveraGen BioPharma, Inc.
Phone: 301-962-1578
EMail: eric.hoffman@reveragen.com
Layout table for additonal information
Responsible Party: ReveraGen BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT02415439    
Other Study ID Numbers: VBP15-001
First Submitted: March 2, 2015
First Posted: April 14, 2015
Results First Submitted: June 9, 2016
Results First Posted: January 5, 2017
Last Update Posted: March 10, 2017