Actively Recruiting
A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
Led by Bambusa Therapeutics · Updated on 2025-05-14
98
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, blinded, placebo-controlled single (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with Chronic Obstructive Pulmonary Disease (COPD).
CONDITIONS
Official Title
A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years for healthy volunteers, 35 to 75 years for patients with COPD
- Body mass index between 18-32 kg/m², weight capped at 120 kg
- Negative pregnancy test for women who can have children
- Willingness to avoid alcohol for 24 hours before each study visit
- Non-smokers, healthy smokers (5 or fewer cigarettes per day), or ex-smokers
- Use of effective contraception by men and women who can have children
- No significant medical abnormalities or history of relevant diseases
- For COPD patients: documented COPD with post-bronchodilator FEV1/FVC less than 0.70
- For COPD patients: FEV1 between 30% and less than 80% of predicted at screening
You will not qualify if you...
- Positive tests for HIV, hepatitis B, or hepatitis C viruses
- History of immunodeficiency, autoimmune disease, cancer, or conditions increasing infection risk
- History of major metabolic, skin, liver, kidney, blood, or other serious disorders
- Abnormal lab results including low blood counts, liver enzymes, or kidney function
- Positive drug or alcohol tests or abnormal vital signs at screening or Day -1
- Abnormal findings on electrocardiogram (ECG)
- History of drug or alcohol abuse in the past 2 years
- History of severe allergic reactions or hypersensitivity
- For COPD patients: diagnosis of other significant lung diseases
- For COPD patients: significant or unstable heart disease
- For COPD patients: recent serious infections
- For COPD patients: inability to perform lung function tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Linear Clinical Research
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
L
Lisa Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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