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NCT06944925PHASE1RecruitingAccepts Healthy Volunteers

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)

Bambusa Therapeutics

Start Date

5/8/2025

Completion Date

7/31/2027

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).

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 80 years

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

Interventions

DRUG

BBT002

DRUG

Placebo

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Conditions

Chronic Obstructive Pulmonary Disease

Locations

Equity Medical Bowling Green

Bowling Green, Kentucky 42104

United States

Equity Medical - Owensboro

Owensboro, Kentucky 42303

United States

Equity Medical LLC

New York, New York 10023

United States

Linear Clinical Research

Perth, Western Australia 6009

Australia

Momentum Clinical Research

Brisbane, 4068

Australia

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0198

Georgia

Geo Hospitals Tbilisi Multiprofile Medical Center

Tbilisi, 0198

Georgia

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, 0198

Georgia

Ltd Aversi Clinic

Tbilisi, 0198

Georgia

Momentum Clinical Research Hamilton

Rotorua, Hamilton 3010

New Zealand

Momentum Clinical Research

Pukekohe, 2120

New Zealand

Momentum Clinical Research

Wellington, 6021

New Zealand

Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz

Gdansk, 80-214

Poland

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

Krakow, 31-011

Poland