Status:
RECRUITING
A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Bambusa Therapeutics
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is a randomized, blinded, placebo-controlled single (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics an...
Detailed Description
The study consists of three parts: * Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) * Part B (three repeated doses in HVs in sequential ascending dose cohorts, MAD ...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria (Parts A, B, C)
- 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
- Key Inclusion Criteria (Part C only)
- Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70
- FEV1 ≥ 30% and FEV1\<80% predicted at screening.
- Key Exclusion Criteria for (Parts A, B, C)
- 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
- Key Exclusion Criteria for (Part C only)
- Current diagnosis of other significant pulmonary disease
- Significant or unstable cardiovascular diseases
- Recent clinically significant infection
- Inability to perform spirometry
Exclusion
Key Trial Info
Start Date :
May 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06944925
Start Date
May 8 2025
End Date
March 31 2027
Last Update
May 14 2025
Active Locations (1)
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1
Linear Clinical Research
Perth, Western Australia, Australia, 6009