NCT07288554

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

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 Participants With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Bambusa Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is 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 Participants with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description

The study consists of two parts: * Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part) * Part B (two repeated doses in patients with COPD, MAD in patients part)

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

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

Timeline

• Start date: 2025-09-05
• Primary completion: 2026-12-31
• Completion: 2027-05-30
• First posted: 2025-12-17
• Last updated: 2026-01-07

Locations

11 sites across 1 country: China

Regulatory

• FDA-regulated drug study