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).
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
The Second Hospital of Anhui Medical Univesity
Hefei, Anhui, China
RECRUITINGThe third affiliated hosptial of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGNumber of participants with adverse events following single and multiple administration of BBT002
Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v5.0.
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
Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis
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.
Blood pressure and heart rate will be assessed.
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.
Physical examination will be assessed.
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
12-lead ECG will be assessed.
Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
PK parameters- maximum observed concentration (Cmax)
Maximum observed concentration of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Time for maximum observed Concentration (Tmax)
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The First Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, China
RECRUITINGJiangmen Central Hospital
Jiangmen, Guangdong, China
RECRUITINGQingyuan People's Hospital
Qingyuan, Guangdong, China
RECRUITINGThe First People's Hospital of Xinxiang City
Xinxiang, Henan, China
RECRUITINGYichang Central People's Hospital
Yichang, Hubei, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGJiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
RECRUITINGChengdu fifth People's Hospital
Chengdu, Sichuang, China
RECRUITING...and 1 more locations
Serum PK Tmax will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Area under the curve (AUC)
Area under the curve of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Volume of distribution (Vz)
Volume of distribution of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Total clearance (CL)
Total clearance of the study drug in serum will be analyzed for all subjects
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- - Elimination Half-life (t1/2)
Elimination half-life of the study drug in serum will be analyzed for all subjects
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).
Serum Anti-Drug Antibodies will be analyzed for all subject
Time frame: At specified timepoints pre-dose and up to 169 days post first dose administration