RecruitingChronic Obstructive Pulmonary Disease (COPD)

To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment

Eligible age

40–85 yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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.

Sponsor: Expedition Therapeutics, Inc

You may qualify if…

✓ 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 maintenance therapy with either dual or triple inhaled therapy for ≥ 3 months prior to enrollment per below:
✓ 1. Dual therapy: long-acting beta-2 agonist/muscarinic antagonist (LABA/LAMA) or inhaled corticosteroids (ICS)/LAMA, or ICS/LABA OR

You may not qualify if…

✕ 1. COPD exacerbation within the 4 weeks prior to randomization.
✕ 2. Clinically important pulmonary disease other than COPD (eg, asthma, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, lung cancer, alpha-1 antitrypsin deficiency, tuberculosis).
✕ 3. Significant immunodeficiency and/or positive serological tests for hepatitis B, hepatitis C, or known human immunodeficiency virus (HIV) infection.
✕ 4. Pneumonia requiring antibiotics or antiviral medication within 28 days prior to Visit 1.
✕ 5. History of clinically significant infection (excluding pneumonia), acute upper or lower respiratory infection, requiring antibiotics or antiviral medication within 14 days prior to Visit 1.
✕ 6. Evidence of active liver disease (with or without ongoing treatment)
✕ 7. Participants with a QT interval, from the ECG conducted at Screening Visit 1, corrected with Fridericia's formula (QTcF) \> 450 msec (or QTcF \> 480 msec in participants with bundle branch block).
✕ 8. Current or history, within the past year of Visit 1, of substance and/or alcohol abuse.