Testing BBT002 in Healthy Volunteers and Adults With COPD or Nasal Polyps
Tests BBT002 against placebo in healthy adults and in adults with COPD or nasal polyps.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Bowling Green, New York, and Owensboro, United StatesSee the 3 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06944925, who can take part
Where in United States
- Equity Medical Bowling GreenBowling Green, United StatesTaking people
- Equity Medical LLCNew York, United StatesTaking people
- Equity Medical OwensboroOwensboro, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bambusa Therapeutics
- Trial code
- NCT06944925EU 2025-523142-28-00
- Record updated
- 1 July 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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; Participants with confirmed diagnosis of CRSwNP.
Exclusion: 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); 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; Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function; Abnormal Electrocardiogram(ECG) findings; Inability to perform spirometry; Consitions interfering with nasal assessments.