Actively Recruiting
A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Led by Bambusa Therapeutics · Updated on 2026-01-07
68
Participants Needed
11
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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, 35-75 years for patients with COPD
- Body mass index between 18-32 kg/m8, 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 or fewer cigarettes per 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 post-bronchodilator FEV1/FVC less than 0.70 (Part B only)
- FEV1 50% or greater and less than 80% predicted at screening (Part B only)
You will not qualify if you...
- Positive viral tests for HIV, hepatitis C virus, or hepatitis B virus
- Immunodeficiencies, autoimmune diseases, cancer, or history of conditions increasing infection risk
- History of major metabolic, skin, liver, kidney, blood, or other significant disorders
- Clinically relevant 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
- Current diagnosis of other significant lung diseases (Part B only)
- Significant or unstable cardiovascular diseases (Part B only)
- Recent clinically significant infection (Part B only)
- Inability to perform spirometry (Part B only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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