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 Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma.
The study consists of two parts: * Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) * Part B (five repeated doses in patients with CRSwNP, MAD in patients part)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
People's Hospital of Peking University
Beijing, Beijing Municipality, China
RECRUITINGThe Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Number of participants with adverse events following single and multiple administration of BBT002
Incidence, relatedness, and severity of AEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Time frame: Part A- Up to Day 141; Part B - Up to Day 169 post first dose administration
Number of participants with change in vital sign measurements following dose administration.
Changes in vital sign measurements, physical examination, clinical laboratory test findings, and 12-lead results.
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 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 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- 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITINGThe Second Hospital of Shandong Province
Jinan, Shandong, China
RECRUITINGQingdao University Hospital
Qingdao, Shandong, China
RECRUITINGThe Affiliated Yuhuangding Hospital of Qingdao University
Yantai, Shandong, China
RECRUITINGZibo Hospital of Shandong University
Zibo, Shandong, China
RECRUITINGRenji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGThe Second Hospital of Chengdu City
Chengdu, Sichuang, China
RECRUITING...and 2 more locations
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)
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- 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