Sign in

NCT07436949RecruitingPhase 1/2

A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) With or Without 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) With or Without Comorbid Asthma

Source: ClinicalTrials.gov · Last updated 22 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
64 (estimated)
First submitted
22 Feb 2026
Start date
2 Mar 2026
Primary completion date
31 Dec 2027
Lead sponsor
Bambusa Therapeutics
Diseases
Asthma
NCT number
NCT07436949

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 64
  • From 2 Mar 2026 to the primary completion date, 31 Dec 2027
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
  • Any sinus/nasal surgery (including polypectomy) within 6 months before screening, History of \>2 prior sinus/nasal surgeries
  • Concurrent nasal conditions that may interfere with study assessments

Other illness

  • Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)
  • Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections
  • History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders
  • History of drug/alcohol abuse in the past 2 years
  • History of severe allergic reactions or hypersensitivity
  • Significant or unstable cardiovascular diseases
  • Recent clinically significant infection

Lab values

  • Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function

Other

  • Abnormal Electrocardiogram(ECG) findings

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
People's Hospital of Peking University
Coordinator of this site? Confirm its status
BeijingChinaRecruiting
Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
The Second Hospital of Chengdu City
Coordinator of this site? Confirm its status
ChengduChinaRecruiting
The Third Affiliated Hospital of Sun Yat-Sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Zhejiang People's Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
The Second Hospital of Shandong Province
Coordinator of this site? Confirm its status
JinanChinaRecruiting
Jiangsu Province Hospital
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Qingdao University Hospital
Coordinator of this site? Confirm its status
QingdaoChinaRecruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
The Second Affiliated Hospital of Wenzhou Medical University
Coordinator of this site? Confirm its status
WenzhouChinaRecruiting
The Affiliated Yuhuangding Hospital of Qingdao University
Coordinator of this site? Confirm its status
YantaiChinaRecruiting
Zibo Hospital of Shandong University
Coordinator of this site? Confirm its status
ZiboChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.