Actively Recruiting
A Randomized, Blinded, 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 COPD Patients
Led by Bambusa Therapeutics · Updated on 2025-05-14
98
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical effects of BBT002 in healthy volunteers and adults with Chronic Obstructive Pulmonary Disease (COPD). This randomized, blinded, placebo-controlled study includes both single and multiple ascending dose parts to better understand how BBT002 behaves and affects these groups. The study is divided into three parts: Part A involves a single dose of BBT002 or placebo given to healthy volunteers; Part B includes three repeated doses in healthy volunteers; and Part C gives two repeated doses to patients with COPD. Each part compares BBT002 to a placebo to assess how the drug is processed and tolerated. Participants will undergo monitoring for adverse events, laboratory changes, vital signs, physical exams, and heart electrical activity for up to 141 days in Part A and 169 days in Parts B and C after dosing. The study also measures drug concentration over time and immune responses. These evaluations help researchers understand safety and how the body handles BBT002 during and after treatment.
CONDITIONS
Brief 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...
- Adults aged 18 to 65 years for healthy volunteers and 35 to 75 years for patients with COPD
- Body mass index between 18 and 32 kg/m8, with a maximum weight of 120 kg
- Negative pregnancy tests for women who can become pregnant
- Willingness to avoid alcohol for 24 hours before each study visit
- Non-smokers, healthy current smokers of 5 or fewer cigarettes per day, or ex-smokers
- Use of effective contraception for men and women who can become pregnant
- No significant health problems or relevant disease history
- For COPD patients only: documented COPD diagnosis with post-bronchodilator FEV1/FVC less than 0.70
- For COPD patients only: FEV1 predicted between 30% and less than 80% at screening
You will not qualify if you...
- Positive tests for HIV, hepatitis C, or hepatitis B viruses
- Immunodeficiencies, autoimmune diseases, 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 electrocardiogram (ECG) findings
- History of drug or alcohol abuse within the past 2 years
- History of severe allergic reactions or hypersensitivity
- For COPD patients only: diagnosis of other significant lung diseases
- For COPD patients only: unstable or significant heart diseases
- For COPD patients only: recent serious infections
- For COPD patients only: inability to perform lung function tests (spirometry)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 169 days post first dose administration
Participants receive one or multiple doses of BBT002 or placebo depending on the study part: a single dose for healthy volunteers in Part A, three repeated doses for healthy volunteers in Part B, or two repeated doses for COPD patients in Part C.
1 to 3 dosing visits depending on study part
Duration - Up to Day 141 for Part A; up to Day 169 for Parts B and C post first dose administration
Participants are monitored for safety, tolerability, and pharmacokinetics after the last dose administration.
Multiple follow-up visits up to Day 169
Trial Site Locations
Total: 1 location
1
Linear Clinical Research
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
L
Lisa Li
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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