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RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients

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: NCT02257177
Recruitment Status : Completed
First Posted : October 6, 2014
Results First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Galecto Biotech AB

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: Inhaled TD139
Drug: Placebo
Enrollment 60
Recruitment Details A total of 60 subjects were randomised, 39 randomized to treatment, with 24 subjects in Part 1 and 15 subjects in Part 2.
Pre-assignment Details  
Arm/Group Title 0.15 mg TD139 (Part 1) 1.5 mg TD139 (Part 1) 3 mg TD139 (Part 1) 10 mg TD139 Part 1 20 mg TD139 Part 1 50 mg TD139 Part 1 Placebo Part 1 0.3 mg TD139 Part 2 3 mg TD139 Part 2 10 mg TD139 Part 2 Placebo Part 2
Hide Arm/Group Description

4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Placebo: DPI placebo

5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder. 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder. 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder. 9 Patients with IPF are administered placebo inhaled as a dry powder.
Period Title: Overall Study
Started 4 4 4 4 4 4 12 5 5 5 9
Completed 4 4 4 4 4 4 12 5 5 4 9
Not Completed 0 0 0 0 0 0 0 0 0 1 0
Arm/Group Title 0.15 mg TD139 (Part 1) 1.5 mg TD139 (Part 1) 3 mg TD139 (Part 1) 10 mg TD139 Part 1 20 mg TD139 Part 1 50 mg TD139 Part 1 Placebo Part 1 0.3 mg TD139 Part 2 3 mg TD139 Part 2 10 mg TD139 Part 2 Placebo Part 2 Total
Hide Arm/Group Description

4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Placebo: DPI placebo

5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder. 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder. 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder. 9 Patients with IPF are administered placebo inhaled as a dry powder. Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 4 4 12 5 5 5 9 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 12 participants 5 participants 5 participants 5 participants 9 participants 60 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%
Between 18 and 65 years
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
12
 100.0%
1
  20.0%
1
  20.0%
0
   0.0%
0
   0.0%
38
  63.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
  80.0%
4
  80.0%
5
 100.0%
9
 100.0%
22
  36.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 12 participants 5 participants 5 participants 5 participants 9 participants 60 participants
42.3  (9.07) 29.8  (6.80) 39.3  (10.21) 29.8  (2.06) 30.8  (9.54) 32.8  (9.91) 35.6  (7.53) 69.0  (6.32) 73.6  (5.86) 79.2  (2.77) 72.9  (4.59) 50.2  (20.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 12 participants 5 participants 5 participants 5 participants 9 participants 60 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.7%
Male
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
12
 100.0%
4
  80.0%
5
 100.0%
5
 100.0%
9
 100.0%
59
  98.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 4 participants 4 participants 4 participants 4 participants 4 participants 4 participants 12 participants 5 participants 5 participants 5 participants 9 participants 60 participants
4 4 4 4 4 4 12 5 5 5 9 60
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.
Time Frame 0 - 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in Part 1 are included in the safety population. The safety population includes all subjects who received at least one dose of study treatment (TD139 or Placebo). Safety parameters are listed and summarised using descriptive statistics. No formal statistical analysis is planned.
Arm/Group Title 0.15 mg TD139 (Part 1) 1.5 mg TD139 (Part 1) 3 mg TD139 (Part 1) 10 mg TD139 Part 1 20 mg TD139 Part 1 50 mg TD139 Part 1 Placebo Part 1 0.3 mg TD139 Part 2 3 mg TD139 Part 2 10 mg TD139 Part 2 Placebo Part 2
Hide Arm/Group Description:

4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Placebo: DPI placebo

5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder.
5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder.
5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder.
9 Patients with IPF are administered placebo inhaled as a dry powder.
Overall Number of Participants Analyzed 4 4 4 4 4 4 12 5 5 5 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2
  50.0%
3
  75.0%
4
 100.0%
4
 100.0%
2
  16.7%
4
  80.0%
5
 100.0%
4
  80.0%
7
  77.8%
Time Frame Adverse Events are measured from the administration of the first dose, until 30 days post first dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.15 mg TD139 (Part 1) 1.5 mg TD139 (Part 1) 3 mg TD139 (Part 1) 10 mg TD139 Part 1 20 mg TD139 Part 1 50 mg TD139 Part 1 Placebo Part 1 0.3 mg TD139 Part 2 3 mg TD139 Part 2 10 mg TD139 Part 2 Placebo Part 2
Hide Arm/Group Description

4 Healthy Subjects are administered a single dose of 0.15mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 1.5mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 3mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 10mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 20mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

4 Healthy Subjects are administered a single dose of 50mg TD139 inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Inhaled TD139: DPI Galectin-3 inhibitor

12 Healthy Subjects are administered placebo inhaled as a dry powder in a fasted state. Each cohort will include a dose leader volunteer to be dosed a day before the rest of the cohort, followed by the remaining 3 subjects who will be dosed approximately 24 hours later.

Placebo: DPI placebo

5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder. 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder. 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder. 9 Patients with IPF are administered placebo inhaled as a dry powder.
All-Cause Mortality
0.15 mg TD139 (Part 1) 1.5 mg TD139 (Part 1) 3 mg TD139 (Part 1) 10 mg TD139 Part 1 20 mg TD139 Part 1 50 mg TD139 Part 1 Placebo Part 1 0.3 mg TD139 Part 2 3 mg TD139 Part 2 10 mg TD139 Part 2 Placebo Part 2
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   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/12 (0.00%)      0/5 (0.00%)      0/5 (0.00%)      1/5 (20.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
0.15 mg TD139 (Part 1) 1.5 mg TD139 (Part 1) 3 mg TD139 (Part 1) 10 mg TD139 Part 1 20 mg TD139 Part 1 50 mg TD139 Part 1 Placebo Part 1 0.3 mg TD139 Part 2 3 mg TD139 Part 2 10 mg TD139 Part 2 Placebo Part 2
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   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/12 (0.00%)      0/5 (0.00%)      0/5 (0.00%)      1/5 (20.00%)      0/9 (0.00%)    
Infections and infestations                       
Pneumonia  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/9 (0.00%)  0
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
0.15 mg TD139 (Part 1) 1.5 mg TD139 (Part 1) 3 mg TD139 (Part 1) 10 mg TD139 Part 1 20 mg TD139 Part 1 50 mg TD139 Part 1 Placebo Part 1 0.3 mg TD139 Part 2 3 mg TD139 Part 2 10 mg TD139 Part 2 Placebo Part 2
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   0/4 (0.00%)      0/4 (0.00%)      2/4 (50.00%)      3/4 (75.00%)      4/4 (100.00%)      4/4 (100.00%)      2/12 (16.67%)      4/5 (80.00%)      5/5 (100.00%)      4/5 (80.00%)      7/9 (77.78%)    
Endocrine disorders                       
Adrenal Suppression  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders                       
Abdominal Pain Upper  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/9 (0.00%)  0
Diarrhoea  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/12 (0.00%)  0 1/5 (20.00%)  1 1/5 (20.00%)  2 0/5 (0.00%)  0 1/9 (11.11%)  2
Dyspepsia  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/9 (0.00%)  0
Vomiting  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/9 (0.00%)  0
General disorders                       
Chills  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1 1/5 (20.00%)  1 0/5 (0.00%)  0 1/9 (11.11%)  1
Fatigue  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Pyrexia  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1 1/5 (20.00%)  1 1/5 (20.00%)  3 1/9 (11.11%)  1
Vessel Puncture Site Pain  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/5 (0.00%)  0 0/9 (0.00%)  0
Infections and infestations                       
Nasopharyngitis  1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Upper Respiratory Tract Infection  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Ear Infection  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Localised Infection  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Lower Respiratory Tract Infection  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/9 (0.00%)  0
Urinary Tract Infection  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 1/5 (20.00%)  1 1/5 (20.00%)  1 0/5 (0.00%)  0 0/9 (0.00%)  0
Injury, poisoning and procedural complications                       
Contusion  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders                       
Back Pain  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/9 (0.00%)  0
Arthralgia  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/9 (0.00%)  0
Flank Pain  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0/5 (0.00%)  0 1/9 (11.11%)  1
Gout  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Musculoskeletal Discomfort  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders                       
Dysgeusia  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 3/4 (75.00%)  3 4/4 (100.00%)  4 4/4 (100.00%)  4 2/12 (16.67%)  2 0/5 (0.00%)  0 1/5 (20.00%)  1 1/5 (20.00%)  1 0/9 (0.00%)  0
Headache  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 2/4 (50.00%)  2 1/4 (25.00%)  1 0/12 (0.00%)  0 1/5 (20.00%)  3 0/5 (0.00%)  0 0/5 (0.00%)  0 2/9 (22.22%)  2
Dizziness  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/9 (0.00%)  0
Sinus Headache  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Renal and urinary disorders                       
Bladder and Urethral Symptoms  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/9 (0.00%)  0
Urinary Retention  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/9 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                       
Cough  1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0 2/4 (50.00%)  2 0/12 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 2/5 (40.00%)  2 1/9 (11.11%)  1
Wheezing  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  2
Dyspnoea  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Oropharyngeal Pain  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/9 (0.00%)  0
Upper-airway Cough Syndrome  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Skin and subcutaneous tissue disorders                       
Actinic Keratosis  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Rash  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Rosacea  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
Seborrheic dermatitis  1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/12 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/9 (11.11%)  1
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
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.
The Investigators must agree to maintain the confidentiality of the study at all times and must not reveal any information relating to the study without express permission from the study Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Bertil Lindmark
Organization: Galecto
Phone: +4570705210
EMail: info@galecto.com
Layout table for additonal information
Responsible Party: Galecto Biotech AB
ClinicalTrials.gov Identifier: NCT02257177    
Other Study ID Numbers: GB-HV-01
First Submitted: September 29, 2014
First Posted: October 6, 2014
Results First Submitted: February 22, 2021
Results First Posted: April 8, 2021
Last Update Posted: April 8, 2021