NCT07436949

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma

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) and Comorbid Asthma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Bambusa Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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) and Comorbid Asthma.

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 (five repeated doses in patients with CRSwNP, MAD in patients part)

Conditions

• Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions

Type	Name	Description
DRUG	BBT002	BBT002 will be administered in part A and part B
DRUG	Placebo	Placebo will be administered

Timeline

• Start date: 2026-03-02
• Primary completion: 2026-12-31
• Completion: 2027-05-30
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

12 sites across 1 country: China

Regulatory

• FDA-regulated drug study