A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Recruiting · NCT07288554 · Interventional (participants receive a specific treatment) · Lead sponsor: Bambusa Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
BBT002Placebo
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- A\&B)
- 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 B only)
- Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70
- FEV1 ≥ 30% and FEV1\<80% predicted at screening.
Exclusion criteria
- part A \& B)
- 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 B only)
- Current diagnosis of other significant pulmonary disease
- Significant or unstable cardiovascular diseases
- Recent clinically significant infection
- Inability to perform spirometry
Where it is running
11 locations listed.
- The Second Hospital of Anhui Medical Univesity - Hefei, Anhui, China
- The third affiliated hosptial of Guangzhou Medical University - Guangzhou, Guangdong, China
- The First Affiliated Hospital of Guangdong Medical University - Guangzhou, Guangdong, China
- Jiangmen Central Hospital - Jiangmen, Guangdong, China
- Qingyuan People's Hospital - Qingyuan, Guangdong, China
- The First People's Hospital of Xinxiang City - Xinxiang, Henan, China
- Yichang Central People's Hospital - Yichang, Hubei, China
- The Affiliated Hospital of Xuzhou Medical University - Xuzhou, Jiangsu, China
- Jiangxi Provincial People's Hospital - Nanchang, Jiangxi, China
- Chengdu fifth People's Hospital - Chengdu, Sichuang, China
- Zhejiang Provincial People's Hospital - Hangzhou, Zhejiang, China