A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BBT002, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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).
Detailed description
The study consists of two parts:
* Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) * Part B (two repeated doses in patients with COPD, MAD in patients part)
Interventions
- Drug BBT002
BBT002 will be administered - Drug Placebo
Placebo will be administered
Primary outcome measures
- Number of participants with adverse events following single and multiple administration of BBT002 [Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
- Number of participants with change in Laboratory assessments [Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
- Number of participants with change in vital sign measurements following dose administration. [Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
- Number of participants with change in physical examination following dose administration. [Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
- Number of participants with change in 12-lead ECG readings [Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration]
Secondary outcome measures (7)
- PK parameters- maximum observed concentration (Cmax) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
- PK parameters- Time for maximum observed Concentration (Tmax) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
- PK parameters- Area under the curve (AUC) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
- PK parameters- Volume of distribution (Vz) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
- PK parameters- Total clearance (CL) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
- PK parameters- - Elimination Half-life (t1/2) [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
- The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA). [Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 11 centers
- The Second Hospital of Anhui Medical Univesity — Hefei
- The third affiliated hosptial of Guangzhou Medical University — Guangzhou
- The First Affiliated Hospital of Guangdong Medical University — Guangzhou
- Jiangmen Central Hospital — Jiangmen
- Qingyuan People's Hospital — Qingyuan
- The First People's Hospital of Xinxiang City — Xinxiang
- Yichang Central People's Hospital — Yichang
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou
- … and 3 more centers
Identifiers
NCT: NCT07288554 · BBT002-002