Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis (NCT NCT03727802)
NCT ID: NCT03727802
Last Updated: 2023-10-23
Results Overview
Number of patients reporting Adverse Events Number of patients by severity reporting Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Up to 14 days after last dose
Results posted on
2023-10-23
Participant Flow
A total of 34 subjects were randomized to treatment, with 16 subjects in Part A and 18 subjects in Part B.
Participant milestones
| Measure |
PartA:TRK-250 2mg
single dose of TRK-250
|
PartA:TRK-250 10mg
single dose of TRK-250
|
PartA:TRK-250 30mg
single dose of TRK-250
|
PartA:TRK-250 60mg
single dose of TRK-250
|
PartA:Pooled Placebo
single dose of Placebo
|
PartB:TRK-250 10mg
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 30mg
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 60mg
multiple doses (4 weeks) of TRK-250
|
PartB:Pooled Placebo
multiple doses (4 weeks) of Placebo
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
4
|
4
|
4
|
4
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
4
|
4
|
4
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
PartA:TRK-250 2mg
n=3 Participants
single dose of TRK-250
|
PartA:TRK-250 10mg
n=3 Participants
single dose of TRK-250
|
PartA:TRK-250 30mg
n=3 Participants
single dose of TRK-250
|
PartA:TRK-250 60mg
n=3 Participants
single dose of TRK-250
|
PartA:Pooled Placebo
n=4 Participants
single dose of Placebo
|
PartB:TRK-250 10mg
n=4 Participants
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 30mg
n=4 Participants
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 60mg
n=4 Participants
multiple doses (4 weeks) of TRK-250
|
PartB:Pooled Placebo
n=6 Participants
multiple doses (4 weeks) of Placebo
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
Age
|
74 years
n=5 Participants
|
70 years
n=7 Participants
|
76 years
n=5 Participants
|
69 years
n=4 Participants
|
75 years
n=21 Participants
|
64 years
n=10 Participants
|
70 years
n=115 Participants
|
74 years
n=6 Participants
|
75 years
n=6 Participants
|
72 years
n=64 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
7 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
27 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
33 Participants
n=64 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after last doseNumber of patients reporting Adverse Events Number of patients by severity reporting Adverse Events
Outcome measures
| Measure |
PartA:TRK-250 2mg
n=3 Participants
single dose of TRK-250
|
PartA:TRK-250 10mg
n=3 Participants
single dose of TRK-250
|
PartA:TRK-250 30mg
n=3 Participants
single dose of TRK-250
|
PartA:TRK-250 60mg
n=3 Participants
single dose of TRK-250
|
PartA:Pooled Placebo
n=4 Participants
single dose of Placebo
|
PartB:TRK-250 10mg
n=4 Participants
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 30mg
n=4 Participants
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 60mg
n=4 Participants
multiple doses (4 weeks) of TRK-250
|
PartB:Pooled Placebo
n=6 Participants
multiple doses (4 weeks) of Placebo
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence and Severity of Adverse Events
Subjects with AEs
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Incidence and Severity of Adverse Events
Mild(Severity)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Incidence and Severity of Adverse Events
Moderate(Severity)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Incidence and Severity of Adverse Events
Severe(Severity)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
PartA:TRK-250 2mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PartA:TRK-250 10mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PartA:TRK-250 30mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PartA:TRK-250 60mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PartA:Pooled Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PartB:TRK-250 10mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PartB:TRK-250 30mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PartB:TRK-250 60mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
PartB:Pooled Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PartA:TRK-250 2mg
n=3 participants at risk
single dose of TRK-250
|
PartA:TRK-250 10mg
n=3 participants at risk
single dose of TRK-250
|
PartA:TRK-250 30mg
n=3 participants at risk
single dose of TRK-250
|
PartA:TRK-250 60mg
n=3 participants at risk
single dose of TRK-250
|
PartA:Pooled Placebo
n=4 participants at risk
single dose of Placebo
|
PartB:TRK-250 10mg
n=4 participants at risk
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 30mg
n=4 participants at risk
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 60mg
n=4 participants at risk
multiple doses (4 weeks) of TRK-250
|
PartB:Pooled Placebo
n=6 participants at risk
multiple doses (4 weeks) of Placebo
|
|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
Other adverse events
| Measure |
PartA:TRK-250 2mg
n=3 participants at risk
single dose of TRK-250
|
PartA:TRK-250 10mg
n=3 participants at risk
single dose of TRK-250
|
PartA:TRK-250 30mg
n=3 participants at risk
single dose of TRK-250
|
PartA:TRK-250 60mg
n=3 participants at risk
single dose of TRK-250
|
PartA:Pooled Placebo
n=4 participants at risk
single dose of Placebo
|
PartB:TRK-250 10mg
n=4 participants at risk
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 30mg
n=4 participants at risk
multiple doses (4 weeks) of TRK-250
|
PartB:TRK-250 60mg
n=4 participants at risk
multiple doses (4 weeks) of TRK-250
|
PartB:Pooled Placebo
n=6 participants at risk
multiple doses (4 weeks) of Placebo
|
|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Investigations
Eosinophil count increased
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Investigations
Heart rate irregular
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
16.7%
1/6 • Up to 14 days after last dose
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
16.7%
1/6 • Up to 14 days after last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
16.7%
1/6 • Up to 14 days after last dose
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
16.7%
1/6 • Up to 14 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
25.0%
1/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/6 • Up to 14 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
33.3%
1/3 • Up to 14 days after last dose
|
0.00%
0/3 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
0.00%
0/4 • Up to 14 days after last dose
|
16.7%
1/6 • Up to 14 days after last dose
|
Additional Information
Clinical Trials Information Desk
Toray Industries, Inc
Phone: +81-3-3245-8576
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60