A Randomized, Double-Blind, Placebo-controlled, Parallel Arm, 52-week Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Two Doses of EXPD-101 in Participants With COPD
Expedition Therapeutics, Inc
Summary
This is a Phase 2 study of the efficacy, safety, tolerability and pharmacokinetics of two doses of EXPD-101 in participants with COPD. Study participants will be randomized to receive either study drug or placebo administered once daily for 52 weeks.
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provided written informed consent for the study 2. Body mass index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2 at screening (weight ≥ 50 kg for males and ≥ 45 kg for females) 3. Diagnosis of COPD for at least 1 year 4. COPD with physician-confirmed diagnosis of chronic bronchitis (persistent, productive cough and sputum for at least 3 months in the past year) 5. At least 2 moderate or \> 1 severe exacerbation within 12 months prior to screening 6. Current or ex-tobacco smokers with history of ≥ 10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year); 7. Stable main…