NCT06944925

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Bambusa Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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).

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)

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	BBT002	BBT002 will be administered.
DRUG	Placebo	Placebo will be administered.

Timeline

• Start date: 2025-05-08
• Primary completion: 2026-10-31
• Completion: 2027-03-31
• First posted: 2025-04-25
• Last updated: 2025-05-14

Locations

1 site across 1 country: Australia