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)

NCT06944925 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BBT002-001
• Study Type: interventional
• Target: 286
• Locations: 5 countries
• Sites: 14

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

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events following single and multiple administration of BBT002

  Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v6.0.

  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

  Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis

  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.

  Blood pressure and heart rate will be assessed.

  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.

  Physical examination will be assessed.

  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

  12-lead ECG will be assessed.

  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

Secondary Outcomes (7)

• PK parameters- maximum observed concentration (Cmax)

  At specified timepoints pre-dose and up to 169 days post first dose administration

• PK parameters- Time of maximum observed Concentration (Tmax)

  At specified timepoints pre-dose and up to 169 days post first dose administration

• PK parameters- Area under the curve (AUC)

  At specified timepoints pre-dose and up to 169 days post first dose administration

• PK parameters- Volume of distribution (Vz)

  At specified timepoints pre-dose and up to 169 days post first dose administration

• PK parameters- Total clearance (CL)

  At specified timepoints pre-dose and up to 169 days post first dose administration

Study Arms (14)

Part A: BBT002

EXPERIMENTAL

A single dose of BBT002 will be administered in healthy volunteers

Drug: BBT002

Part B: BBT002

EXPERIMENTAL

Multiple doses of BBT002 will be administered in healthy volunteers.

Drug: BBT002

Part C: BBT002

EXPERIMENTAL

Multiple doses of BBT002 will be administered in patients with COPD

Drug: BBT002

Part A: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part B: Placebo

PLACEBO COMPARATOR

Multiple doses of Placebo will be administered in healthy volunteers.

Drug: Placebo

Part C: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part D: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part E: Placebo

PLACEBO COMPARATOR

Single dose of Placebo will be administered in healthy volunteers.

Drug: Placebo

Part F: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part G: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part D: BBT002

EXPERIMENTAL

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

Drug: BBT002

Part E: BBT002

EXPERIMENTAL

Single dose of BBT002 will be administered in healthy volunteers.

Drug: BBT002

Part F: BBT002

EXPERIMENTAL

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

Drug: BBT002

Part G: BBT002

EXPERIMENTAL

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

Drug: BBT002

Interventions

BBT002 DRUG

BBT002 will be administered.

Part A: BBT002; Part B: BBT002; Part C: BBT002; Part D: BBT002; Part E: BBT002; Part F: BBT002; Part G: BBT002

Placebo DRUG

Placebo will be administered.

Part A: Placebo; Part B: Placebo; Part C: Placebo; Part D: Placebo; Part E: Placebo; Part F: Placebo; Part G: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
• Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
• Abnormal Electrocardiogram(ECG) findings
• 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
• Inability to perform spirometry
• Steroid refractoriness: Refractory to systemic corticosteriods for CRSwNP
• Sinonasal surgery (recent/extensiv)
• Consitions interfering with nasal assessments

Sponsors & Collaborators

• Bambusa Therapeutics: lead

Study Sites (14)

Equity Medical Bowling Green

Bowling Green, Kentucky, 42104, United States

RECRUITING

Equity Medical - Owensboro

Owensboro, Kentucky, 42303, United States

NOT YET RECRUITING

Equity Medical LLC

New York, New York, 10023, United States

RECRUITING

Linear Clinical Research

Perth, Western Australia, 6009, Australia

RECRUITING

Momentum Clinical Research

Brisbane, 4068, Australia

RECRUITING

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0198, Georgia

RECRUITING

Geo Hospitals Tbilisi Multiprofile Medical Center

Tbilisi, 0198, Georgia

RECRUITING

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, 0198, Georgia

RECRUITING

Ltd Aversi Clinic

Tbilisi, 0198, Georgia

RECRUITING

Momentum Clinical Research Hamilton

Rotorua, Hamilton, 3010, New Zealand

NOT YET RECRUITING

Momentum Clinical Research

Pukekohe, 2120, New Zealand

RECRUITING

Momentum Clinical Research

Wellington, 6021, New Zealand

RECRUITING

Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz

Gdansk, 80-214, Poland

NOT YET RECRUITING

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

Krakow, 31-011, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tracy Ji

  Bambusa Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Tracy Ji

CONTACT

+86 18001322760; Tracy.Ji@bambusatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

AU (2); US (3); GE (4); NZ (3); PL (2)