A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in HVs and COPD Patients

This study is a randomized, blinded, placebo-controlled single (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with Chronic Obstructive Pulmonary Disease (COPD).

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Placebo; Drug: BBT002

Detailed Description

The study consists of three parts:

• Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part)
• Part B (three repeated doses in HVs in sequential ascending dose cohorts, MAD in HVs part)
• Part C (two repeated doses in patients with COPD, MAD in patients part)

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lisa Li; Phone Number: +1 858 353 4948; Email: Lisa.Li@bambusatx.com

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Recruiting
      • Linear Clinical Research
      • Contact: Lara Hatchuel, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria (Parts A, B, C)

1. Age of 18-65 years (HVs), 35-75 years (patients)
2. Body mass index between 18-32 kg/m², capped at 120 kg
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 only)

1. Documented history of COPD with a post-bronchodilator FEV1/FVC < 0.70
2. FEV1 ≥ 30% and FEV1<80% predicted at screening.

Key Exclusion Criteria for (Parts A, B, C)

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 for (Part C 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Part B Multiple Ascending Dose Placebo; Three doses of Placebo will be administered in healthy volunteers.	Drug: Placebo; Placebo will be administered.
Experimental: Part A Single Ascending Dose BBT002; A single dose of BBT002 will be administered in healthy volunteers	Drug: BBT002; BBT002 will be administered.
Experimental: Part B Multiple Ascending Dose BBT002; Three doses of BBT002 will be administered in healthy volunteers.	Drug: BBT002; BBT002 will be administered.
Experimental: Part C Multiple Ascending Dose BBT002; Two doses of BBT002 will be administered in patients with COPD.	Drug: BBT002; BBT002 will be administered.
Placebo Comparator: Part A Single Ascending Dose Placebo; A single dose of Placebo will be administered in healthy volunteers.	Drug: Placebo; Placebo will be administered.
Placebo Comparator: Part C Multiple Ascending Dose Placebo; Two doses of Placebo will be administered in patients with COPD.	Drug: Placebo; Placebo 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	Incidence, relatedness, and severity of adverse events (AEs) graded per CTCAE v5.0.	Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Number of participants with change in Laboratory assessments	Laboratory assessments include hematology, coagulation, clinical chemistry and urinalysis	Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Number of participants with change in vital sign measurements following dose administration.	Blood pressure and heart rate will be assessed.	Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Number of participants with change in physical examination following dose administration.	Physical examination will be assessed.	Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Number of participants with change in 12-lead ECG readings	12-lead ECG will be assessed.	Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters- maximum observed concentration (Cmax)	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- Time for maximum observed Concentration (Tmax)	Serum PK Tmax 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)	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)	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)	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).	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).	Serum Anti-Drug Antibodies will be analyzed for all subjects	At specified timepoints pre-dose and up to 169 days post first dose administration

Collaborators and Investigators

• Sponsor: Bambusa Therapeutics
• Investigators: Study Director: Lisa Li, Bambusa Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 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): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BBT002-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No