NCT06944925RecruitingPhase 1
A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD) or Chronic Rhiosininusitis With Nasal Polyps (CRSwNP)
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 Patients With COPD or CRSwNP
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
Randomized study of single and multiple doses of BBT002 in healthy volunteers and in adult patients with chronic obstructive pulmonary disease (COPD) or chronic rhinosinusitis with nasal polyps (CRSwNP).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- First submitted
- 18 Apr 2025
- Start date
- 8 May 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Bambusa Therapeutics
- NCT number
- NCT06944925
- EU CT number
- 2025-523142-28-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 286
- From 8 May 2025 to the primary completion date, 31 Jan 2027
- 17 sites in 5 countries
- 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, not your situation.
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
- Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP
- Sinonasal surgery (recent/extensiv)
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
- Current diagnosis of other significant pulmonary disease
- Significant or unstable cardiovascular diseases
- Recent clinically significant infection
- Excluded sinonasal/systemic diseases
Lab values
- Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
Other
- Abnormal Electrocardiogram(ECG) findings
- Inability to perform spirometry
- Consitions interfering with nasal assessments
Who the study is looking for
- Age 18-65 years for HVs (Parts A, B, and E); age 35-80 years for patients with COPD (Parts C and F,); age 18-80 for patients with CRSwNP (Parts D and G)
- Body mass index between 18.0-32.0 kg/m square, capped weight at 120kg, for HVs (Parts A, B, and E); body mass index between 16.0-35.0 kg/m square, capped weight at 125kg for patients (Parts C, D, F, and G)
- 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
- Adequate contraception use (for men and women of childbearing potential)
- No clinically significant abnormalities or history of relevant diseases
- 1\. Participants with confirmed diagnosis of CRSwNP
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Momentum Clinical Research Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| LTD Aversi Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Geo Hospitals Tbilisi Multiprofile Medical Center Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| LEPL The First University Clinic of Tbilisi State Medical University Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Aleksandre Aladashvili Clinic LLC Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Momentum Clinical Research Coordinator of this site? Confirm its status | Pukekohe | New Zealand | Recruiting |
| Momentum Clinical Research Hamilton Coordinator of this site? Confirm its status | Rotorua | New Zealand | Not yet recruiting |
| Momentum Clinical Research Coordinator of this site? Confirm its status | Wellington | New Zealand | Recruiting |
| Centrum Medyczne Kwiatowa Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne w Gdańsku Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| BioResearch Group sp. z o.o. Coordinator of this site? Confirm its status | Nadarzyn | Poland | Recruiting |
| Centrum Wsparcia Badań Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie Coordinator of this site? Confirm its status | Szczecin | Poland | Recruiting |
| Equity Medical Bowling Green Coordinator of this site? Confirm its status | Bowling Green | United States | Recruiting |
| Equity Medical LLC Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Equity Medical Owensboro Coordinator of this site? Confirm its status | Owensboro | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.