Actively Recruiting
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)
Led by Bambusa Therapeutics · Updated on 2026-01-07
68
Participants Needed
11
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 clinical activity of a drug called BBT002 in healthy volunteers and people with Chronic Obstructive Pulmonary Disease (COPD). The study is randomized, double-blind, and placebo-controlled, involving both single and multiple ascending doses. It aims to understand how the drug behaves in the body and its clinical effects in these two groups. The study has two parts. Part A involves healthy volunteers receiving a single dose of either BBT002 or a placebo in sequential ascending dose groups. Part B includes patients with COPD who receive two repeated doses of BBT002 or placebo. The dosing schedules and administration differ between the healthy volunteers and COPD patients, with placebo groups matched accordingly. Participants will be monitored for changes in adverse events, lab tests, vital signs, physical exams, and ECG readings up to 141 days for healthy volunteers and 169 days for COPD patients after the first dose. Researchers will also measure drug concentration levels over time and check for immune responses to BBT002. The total participation period involves multiple assessments to track safety and drug activity.
CONDITIONS
Brief Title
A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years for healthy volunteers and 35-75 years for patients with COPD
- Body mass index between 18-32 kg/m², capped at 120 kg
- Negative pregnancy tests for women of childbearing potential
- Willingness to avoid alcohol for 24 hours before each study visit
- Non-smokers, healthy current smokers (5 or fewer cigarettes per day), or ex-smokers
- Adequate contraception use for men and women of childbearing potential
- No clinically significant abnormalities or relevant disease history
- For COPD patients only: documented COPD with post-bronchodilator FEV1/FVC < 0.70
- For COPD patients only: FEV1 between 50% and less than 80% predicted at screening
You will not qualify if you...
- Positive viral tests for HIV, hepatitis B, or hepatitis C
- Immunodeficiencies, autoimmune diseases, cancer, or history of infection-prone conditions
- History of major metabolic, skin, liver, kidney, blood, or other significant 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 ECG findings
- History of drug or alcohol abuse in past 2 years
- History of severe allergic reactions or hypersensitivity
- For COPD patients only: current diagnosis of other significant lung diseases
- For COPD patients only: significant or unstable heart diseases
- For COPD patients only: recent serious infections
- For COPD patients only: inability to perform required lung function test 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 either a single dose (healthy volunteers) or two doses (patients with COPD) of the study drug BBT002 or placebo to evaluate safety, tolerability, and pharmacokinetics.
Several visits for dosing and assessments over up to 169 days
Trial Site Locations
Total: 11 locations
1
The Second Hospital of Anhui Medical Univesity
Hefei, Anhui, China, 230601
Actively Recruiting
2
The third affiliated hosptial of Guangzhou Medical University
Guangzhou, Guangdong, China, 020-81292183
Not Yet Recruiting
3
The First Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, China, 510000
Active, Not Recruiting
4
Jiangmen Central Hospital
Jiangmen, Guangdong, China, 529000
Not Yet Recruiting
5
Qingyuan People's Hospital
Qingyuan, Guangdong, China
Not Yet Recruiting
6
The First People's Hospital of Xinxiang City
Xinxiang, Henan, China, 453000
Not Yet Recruiting
7
Yichang Central People's Hospital
Yichang, Hubei, China, 443000
Not Yet Recruiting
8
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221002
Not Yet Recruiting
9
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
10
Chengdu fifth People's Hospital
Chengdu, Sichuang, China, 611130
Not Yet Recruiting
11
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
Research Team
T
Tracy Ji, Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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