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)

June 28, 2026 updated by: Bambusa Therapeutics

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

286

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Brisbane, Australia, 4068
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Recruiting
        • Linear Clinical Research
        • Contact:
          • Lara Hatchuel, Dr
        • Principal Investigator:
          • Dr. Lara Hatchuel
  • Georgia
      • Tbilisi, Georgia, 0198
        • Recruiting
        • Aleksandre Aladashvili Clinic LLC
        • Contact:
        • Principal Investigator:
          • Dr. Sopiko Kruashvili
      • Tbilisi, Georgia, 0198
        • Recruiting
        • Geo Hospitals Tbilisi Multiprofile Medical Center
        • Contact:
        • Principal Investigator:
          • Elene Khurtsidze
      • Tbilisi, Georgia, 0198
        • Recruiting
        • LEPL The First University Clinic of Tbilisi State Medical University
        • Contact:
        • Principal Investigator:
          • Dr. Shorena Khazaradze
      • Tbilisi, Georgia, 0198
        • Recruiting
        • LTD Aversi Clinic
        • Contact:
        • Principal Investigator:
          • David Tchkonia
  • New Zealand
      • Pukekohe, New Zealand, 2120
      • Wellington, New Zealand, 6021
        • Recruiting
        • Momentum Clinical Research
        • Contact:
        • Principal Investigator:
          • Dr Dean Quinn
    • Hamilton
      • Rotorua, Hamilton, New Zealand, 3010
        • Not yet recruiting
        • Momentum Clinical Research Hamilton
        • Contact:
        • Principal Investigator:
          • Dr Victoria Siriett
  • Poland
      • Gdansk, Poland, 80-214
        • Not yet recruiting
        • Uniwersyteckie Centrum Kliniczne Osrodka Badan Klinicznych Wczesnych Faz
        • Contact:
        • Principal Investigator:
          • Iwona Damps-Konstanska
      • Krakow, Poland, 31-011
        • Not yet recruiting
        • Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
        • Contact:
        • Principal Investigator:
          • Katarzyna Gajda
  • United States
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Recruiting
        • Equity Medical Bowling Green
        • Contact:
        • Principal Investigator:
          • Dr. James Allred
      • Owensboro, Kentucky, United States, 42303
        • Not yet recruiting
        • Equity Medical - Owensboro
        • Contact:
        • Principal Investigator:
          • Dr. David Johnsonn
    • New York
      • New York, New York, United States, 10023
        • Recruiting
        • Equity Medical LLC
        • Contact:
        • Principal Investigator:
          • Dr. Monalyn Zousias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: BBT002
A single dose of BBT002 will be administered in healthy volunteers
Drug: BBT002
BBT002 will be administered.
Experimental: Part B: BBT002
Multiple doses of BBT002 will be administered in healthy volunteers.
Drug: BBT002
BBT002 will be administered.
Experimental: Part C: BBT002
Multiple doses of BBT002 will be administered in patients with COPD
Drug: BBT002
BBT002 will be administered.
Placebo Comparator: Part A: Placebo
A single dose of Placebo will be administered in healthy volunteers.
Drug: Placebo
Placebo will be administered.
Placebo Comparator: Part B: Placebo
Multiple doses of Placebo will be administered in healthy volunteers.
Drug: Placebo
Placebo will be administered.
Placebo Comparator: Part C: Placebo
Multiple doses of Placebo will be administered in patients with COPD.
Drug: Placebo
Placebo will be administered.
Placebo Comparator: Part D: Placebo
Multiple doses of Placebo will be administered in patients with CRSwNP.
Drug: Placebo
Placebo will be administered.
Placebo Comparator: Part E: Placebo
Single dose of Placebo will be administered in healthy volunteers.
Drug: Placebo
Placebo will be administered.
Placebo Comparator: Part F: Placebo
Multiple doses of Placebo will be administered in patients with COPD.
Drug: Placebo
Placebo will be administered.
Placebo Comparator: Part G: Placebo
Multiple doses of Placebo will be administered in patients with CRSwNP.
Drug: Placebo
Placebo will be administered.
Experimental: Part D: BBT002
Multiple doses of BBT002 will be administered in patients with CRSwNP.
Drug: BBT002
BBT002 will be administered.
Experimental: Part E: BBT002
Single dose of BBT002 will be administered in healthy volunteers.
Drug: BBT002
BBT002 will be administered.
Experimental: Part F: BBT002
Multiple doses of BBT002 will be administered in patients with COPD.
Drug: BBT002
BBT002 will be administered.
Experimental: Part G: BBT002
Multiple doses of BBT002 will be administered in patients with CRSwNP.
Drug: BBT002
BBT002 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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.
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
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.
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
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK parameters- maximum observed concentration (Cmax)
Time Frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Maximum observed concentration of the study drug in serum will be analyzed for all subjects
At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Area under the curve (AUC)
Time Frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Area under the curve of the study drug in serum will be analyzed for all subjects
At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Volume of distribution (Vz)
Time Frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Volume of distribution of the study drug in serum will be analyzed for all subjects
At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Total clearance (CL)
Time Frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Total clearance of the study drug in serum will be analyzed for all subjects
At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- - Elimination Half-life (t1/2).
Time Frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Elimination half-life of the study drug in serum will be analyzed for all subjects
At specified timepoints pre-dose and up to 169 days post first dose administration
The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).
Time Frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Serum Anti-Drug Antibodies will be analyzed for all subjects
At specified timepoints pre-dose and up to 169 days post first dose administration
PK parameters- Time of maximum observed Concentration (Tmax)
Time Frame: At specified timepoints pre-dose and up to 169 days post first dose administration
Serum PK Tmax will be analyzed for all subjects
At specified timepoints pre-dose and up to 169 days post first dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bambusa Therapeutics

Investigators

  • Study Director: Tracy Ji, Bambusa Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 28, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBT002-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe