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)

Last updated: June 28, 2026
Sponsor: Bambusa Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

BBT002

Placebo

Clinical Study ID

NCT06944925
BBT002-001
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria (Parts A, B, C, D, E, F, and G)

  1. 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)

  2. 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)

  3. Negative pregnancy tests for women of childbearing potential

  4. Willingness to refrain from alcohol consumption for 24 hours prior to each study visit

  5. Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers

  6. Adequate contraception use (for men and women of childbearing potential)

  7. No clinically significant abnormalities or history of relevant diseases

Key Inclusion Criteria (Part C and F only) 1. Documented history of COPD with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity less than 0.70

Key Inclusion Criteria (Parts D and G)

  1. Participants with confirmed diagnosis of CRSwNP

Key Exclusion Criteria for (Parts A, B, C, D, E, F, and G)

  1. Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)

  2. Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections

  3. History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders

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

  5. Positive drug/alcohol tests or abnormal vital signs at screening or Day -1

  6. Abnormal Electrocardiogram(ECG) findings

  7. History of drug/alcohol abuse in the past 2 years

  8. History of severe allergic reactions or hypersensitivity

Key Exclusion Criteria (Part C and F only)

  1. Current diagnosis of other significant pulmonary disease

  2. Significant or unstable cardiovascular diseases

  3. Recent clinically significant infection

  4. Inability to perform spirometry

Key Exclusion Criteria (Parts D and G)

  1. Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP

  2. Sinonasal surgery (recent/extensiv)

  3. Consitions interfering with nasal assessments

  4. Excluded sinonasal/systemic diseases

Study Design

Total Participants: 286
Treatment Group(s): 2
Primary Treatment: BBT002
Phase: 1
Study Start date:
May 08, 2025
Estimated Completion Date:
July 31, 2027

Study Description

This study a is a randomized, double-blinded, placebo-controlled single (SAD) and multiple-ascending dose (MAD) study to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with COPD or CRSwNP. BBT002 is a drug candidate being developed for the treatment of COPD or CRSwNP. BBT002 will be given by intravenous injection or subcutaneous injection.

Connect with a study center

  • Linear Clinical Research

    Perth, Western Australia 6009
    Australia

    Active - Recruiting

  • Momentum Clinical Research

    Brisbane, 4068
    Australia

    Active - Recruiting

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0198
    Georgia

    Active - Recruiting

  • Geo Hospitals Tbilisi Multiprofile Medical Center

    Tbilisi, 0198
    Georgia

    Active - Recruiting

  • LEPL The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0198
    Georgia

    Active - Recruiting

  • Ltd Aversi Clinic

    Tbilisi, 0198
    Georgia

    Active - Recruiting

  • Momentum Clinical Research Hamilton

    Rotorua, Hamilton 3010
    New Zealand

    Site Not Available

  • Momentum Clinical Research

    Pukekohe, 2120
    New Zealand

    Active - Recruiting

  • Momentum Clinical Research

    Wellington, 6021
    New Zealand

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz

    Gdansk, 80-214
    Poland

    Site Not Available

  • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

    Krakow, 31-011
    Poland

    Site Not Available

  • Equity Medical Bowling Green

    Bowling Green, Kentucky 42104
    United States

    Active - Recruiting

  • Equity Medical - Owensboro

    Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Equity Medical LLC

    New York, New York 10023
    United States

    Active - Recruiting

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