Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Clinical Trials
Find Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Clinical Trials Near You
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 Comorbid Asthma
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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) with or without Asthma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
• Age of 18-55 years (HVs), 18-75 years (patients)
• Body mass index between 18-30 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
• Participants with physician-diagnosed CRSwNP before screening.
• SNOT-22 total score ≥30 at screening and randomization.
• Documented systemic corticosteroid use (or contraindication/intolerance) within past 24 months.
• Diagnosed asthma per GINA 2025, stable for ≥12 months. Stable on GINA Step 3 or higher therapy for 6 weeks before screening.
• For the participants have comorbid asthma, they had to be stable using their regular asthma treatment.
Locations
Other Locations
China
People's Hospital of Peking University
RECRUITING
Beijing
Xiangya Hospital of Central South University
RECRUITING
Changsha
The Second Hospital of Chengdu City
RECRUITING
Chengdu
The Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Zhejiang People's Hospital
RECRUITING
Hangzhou
The Second Hospital of Shandong Province
RECRUITING
Jinan
Jiangsu Province Hospital
RECRUITING
Nanjing
Qingdao University Hospital
RECRUITING
Qingdao
Renji Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
The Second Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The Affiliated Yuhuangding Hospital of Qingdao University
RECRUITING
Yantai
Zibo Hospital of Shandong University
RECRUITING
Zibo
Contact Information
Primary
Tracy Ji, Senior study Director
Tracy.Ji@bambusatx.com
+86 18001322760
Time Frame
Start Date:2026-03-02
Estimated Completion Date:2028-06-30
Participants
Target number of participants:64
Treatments
Experimental: Part A Single Ascending Dose BBT002
A single dose of BBT002 will be administered in healthy volunteers
Experimental: Part B Multiple Ascending Dose BBT002
Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma
Placebo_comparator: Part A Single Ascending Dose Placebo
A single dose of Placebo will be administered in healthy volunteers.
Placebo_comparator: Part B Multiple Ascending Dose Placebo
Five doses of BBT002 will be administered in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) with or without Asthma