A Phase 1/2 interventional study of BBT002 and Placebo in Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), sponsored by Bambusa Therapeutics. Recruiting at 12 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Bambusa Therapeutics · Phase 1/2, Interventional, and Treatment
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:
Inclusion Criteria: Part (A\&B):
Key Inclusion Criteria (Part B only)
Exclusion Criteria:Part (A\&B):
Key Exclusion Criteria for (Part B only):
A single dose of BBT002 will be administered in healthy volunteers
Drug: BBT002
Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma
Drug: BBT002
A single dose of Placebo will be administered in healthy volunteers.
Drug: Placebo
Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma
Drug: Placebo
BBT002 will be administered.
Placebo will be administered
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
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
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Bambusa Therapeutics