RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Drug: Inhaled TD139Drug: Placebo
- Registration Number
- NCT02257177
- Lead Sponsor
- Galecto Biotech AB
- Brief Summary
This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre, placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety, tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2 will be a randomized, double-blind, multi-centre, placebo-controlled, multiple dose expansion cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male subjects and female subjects of non child-bearing potential with IPF.
- Detailed Description
Up to 6 cohorts of 6 subjects will be randomly assigned in a blinded fashion to receive either a single dose of TD139 or matching placebo via DPI (dry powder inhaler) in an ascending dose fashion.
A single cohort of up to 24 patients will be randomly assigned in a blinded fashion to receive a single dose of TD139 or placebo via DPI once daily for 14 days in a 2:1 TD139 to placebo ratio. The dose of TD139 selected will be based on data from Part 1 and on pre-clinical efficacy and safety data.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 mg TD139 Part 2 Inhaled TD139 5 Patients with IPF are administered a single dose of 3mg TD139 once daily for 14 days inhaled as a dry powder. 3 mg TD139 (Part 1) Inhaled TD139 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. 20 mg TD139 Part 1 Inhaled TD139 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. 10 mg TD139 Part 2 Inhaled TD139 5 Patients with IPF are administered a single dose of 10mg TD139 once daily for 14 days inhaled as a dry powder. 1.5 mg TD139 (Part 1) Inhaled TD139 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. 10 mg TD139 Part 1 Inhaled TD139 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. 0.3 mg TD139 Part 2 Inhaled TD139 5 Patients with IPF are administered a single dose of 0.3mg TD139 once daily for 14 days inhaled as a dry powder. Placebo Part 2 Placebo 9 Patients with IPF are administered placebo inhaled as a dry powder. Placebo Part 1 Placebo 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. 0.15 mg TD139 (Part 1) Inhaled TD139 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. 50 mg TD139 Part 1 Inhaled TD139 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events 0 - 30 days Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Royal Devon & Exeter Foundation NHS Trust
🇬🇧Exeter, Devon, United Kingdom
Edinburgh University Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle, Tyne And Wear, United Kingdom
Simbec Research Limited
🇬🇧Merthyr Tydfil, Wales, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom