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

NCT06944925 | Recruiting Phase 1 DMC

• 1 other identifier: BBT002-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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).

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 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 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 for 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 (6)

Part A Single Ascending Dose BBT002

EXPERIMENTAL

A single dose of BBT002 will be administered in healthy volunteers

Drug: BBT002

Part B Multiple Ascending Dose BBT002

EXPERIMENTAL

Three doses of BBT002 will be administered in healthy volunteers.

Drug: BBT002

Part C Multiple Ascending Dose BBT002

EXPERIMENTAL

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

Drug: BBT002

Part A Single Ascending Dose Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part B Multiple Ascending Dose Placebo

PLACEBO COMPARATOR

Three doses of Placebo will be administered in healthy volunteers.

Drug: Placebo

Part C Multiple Ascending Dose Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

BBT002 DRUG

BBT002 will be administered.

Part A Single Ascending Dose BBT002; Part B Multiple Ascending Dose BBT002; Part C Multiple Ascending Dose BBT002

Placebo DRUG

Placebo will be administered.

Part A Single Ascending Dose Placebo; Part B Multiple Ascending Dose Placebo; Part C Multiple Ascending Dose Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18-65 years (HVs), 35-75 years (patients)
• Body mass index between 18-32 kg/m², capped at 120 kg
• 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
• Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70
• FEV1 ≥ 30% and FEV1\<80% predicted at screening.

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

Sponsors & Collaborators

• Bambusa Therapeutics: lead

Study Sites (1)

Linear Clinical Research

Perth, Western Australia, 6009, Australia

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

• Lisa Li

  Bambusa Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Lisa Li

CONTACT

+1 858 353 4948; Lisa.Li@bambusatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON 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): October 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

AU (1)