A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Randomized, Double-Blind, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Participants With Chronic Obstructive Pulmonary Disease (COPD)
Bambusa Therapeutics
68 participants
Sep 5, 2025
INTERVENTIONAL
Conditions
Summary
This study is a randomized, double-Blind, placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in Healthy Volunteers and Participants with Chronic Obstructive Pulmonary Disease (COPD).
Eligibility
Inclusion Criteria9
- Age of 18-65 years (HVs), 35-75 years (patients)
- Body mass index between 18-32 kg/m², capped at 120 kg
- Negative pregnancy tests for women of childbearing potential
- Willingness to refrain from alcohol consumption for 24 hours prior to each study visit
- Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers
- Adequate contraception use (for men and women of childbearing potential)
- No clinically significant abnormalities or history of relevant diseases
- Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70
- FEV1 ≥ 50% and FEV1\<80% predicted at screening.
Exclusion Criteria12
- Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)
- Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections
- History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders
- Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
- Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
- Abnormal Electrocardiogram(ECG) findings
- History of drug/alcohol abuse in the past 2 years
- History of severe allergic reactions or hypersensitivity
- Current diagnosis of other significant pulmonary disease
- Significant or unstable cardiovascular diseases
- Recent clinically significant infection
- Inability to perform spirometry
Interventions
BBT002 will be administered
Placebo will be administered
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT07288554