Recruiting
Phase 1

BBT002

Sponsor:

Bambusa Therapeutics

Code:

NCT06944925

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

BBT002

Placebo

Study Details

Brief 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).

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT06944925

Start date

May 8, 2025

Status verified date

Jun, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

286 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: BBT002

A single dose of BBT002 will be administered in healthy volunteers

experimental: Part B: BBT002

Multiple doses of BBT002 will be administered in healthy volunteers.

experimental: Part C: BBT002

Multiple doses of BBT002 will be administered in patients with COPD

placebo comparator: Part A: Placebo

A single dose of Placebo will be administered in healthy volunteers.

placebo comparator: Part B: Placebo

Multiple doses of Placebo will be administered in healthy volunteers.

placebo comparator: Part C: Placebo

Multiple doses of Placebo will be administered in patients with COPD.

placebo comparator: Part D: Placebo

Multiple doses of Placebo will be administered in patients with CRSwNP.

placebo comparator: Part E: Placebo

Single dose of Placebo will be administered in healthy volunteers.

placebo comparator: Part F: Placebo

Multiple doses of Placebo will be administered in patients with COPD.

placebo comparator: Part G: Placebo

Multiple doses of Placebo will be administered in patients with CRSwNP.

experimental: Part D: BBT002

Multiple doses of BBT002 will be administered in patients with CRSwNP.

experimental: Part E: BBT002

Single dose of BBT002 will be administered in healthy volunteers.

experimental: Part F: BBT002

Multiple doses of BBT002 will be administered in patients with COPD.

experimental: Part G: BBT002

Multiple doses of BBT002 will be administered in patients with CRSwNP.

Interventions

BBT002

BBT002 will be administered.

Placebo

Placebo will be administered.

Primary outcome measure

  • Number of participants with adverse events following single and multiple administration of BBT002 [ Time Frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration ]
  • Number of participants with change in Laboratory assessments [ Time Frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration ]
  • Number of participants with change in vital sign measurements following dose administration. [ Time Frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration ]
  • Number of participants with change in physical examination following dose administration. [ Time Frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration ]
  • Number of participants with change in 12-lead ECG readings [ Time Frame: Parts A and E - up to 141 days post first dose administration; Parts B, C, D, F, and G - up to 169 days post first dose administration ]

Central Contacts and Locations

Locations

Equity Medical Bowling Green

Recruiting

Bowling Green, Kentucky, United States, 42104

Contacts

Principal Investigator:

Dr. James Allred

Equity Medical LLC

Recruiting

New York, New York, United States, 10023

Contacts

Principal Investigator:

Dr. Monalyn Zousias

More Information

Sponsor

Bambusa Therapeutics

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bambusa Therapeutics on 2026-07-01.