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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria:( A\&B)
1. Age of 18-65 years (HVs), 35-75 years (patients)
2. Body mass index between 18-32 kg/m², capped at 120 kg
3. Negative pregnancy tests for women of childbearing potential
4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit
5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers
6. Adequate contraception use (for men and women of childbearing potential)
7. No clinically significant abnormalities or history of relevant diseases
Key Inclusion Criteria (Part B only)
1. Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70
2. FEV1 ≥ 30% and FEV1\<80% predicted at screening.
Exclusion Criteria:( part A \& B)
1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)
2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections
3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders
4. Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
5. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
6. Abnormal Electrocardiogram(ECG) findings
7. History of drug/alcohol abuse in the past 2 years
8. History of severe allergic reactions or hypersensitivity
Key Exclusion Criteria for (Part B only)
1. Current diagnosis of other significant pulmonary disease
2. Significant or unstable cardiovascular diseases
3. Recent clinically significant infection
4. Inability to perform spirometry
Primary outcome measure(s)
Number of participants with adverse events following single and multiple administration of BBT002 — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v5.0.
Number of participants with change in Laboratory assessments — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
Number of participants with change in vital sign measurements following dose administration. — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration Blood pressure and heart rate will be assessed.
Number of participants with change in physical examination following dose administration. — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration Physical examination will be assessed.
Number of participants with change in 12-lead ECG readings — Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration 12-lead ECG will be assessed.
Trial sites (11)
Facility
City
Region
Status
The Second Hospital of Anhui Medical Univesity
Hefei
Anhui
Recruiting
The third affiliated hosptial of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
The First Affiliated Hospital of Guangdong Medical University
Guangzhou
Guangdong
Recruiting
Jiangmen Central Hospital
Jiangmen
Guangdong
Recruiting
Qingyuan People's Hospital
Qingyuan
Guangdong
Recruiting
The First People's Hospital of Xinxiang City
Xinxiang
Henan
Recruiting
Yichang Central People's Hospital
Yichang
Hubei
Recruiting
The Affiliated Hospital of Xuzhou Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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