BBT002 in healthy adults and adults with 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)

This tests BBT002 versus placebo in healthy adults and people with COPD to see if it is safe and how the body responds to it.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Bambusa Therapeutics (industry)
• Locations: 11 sites (Hefei, Anhui and 10 other locations)
• Trial ID: NCT07288554 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose program. Part A enrolls healthy volunteers in sequential single-ascending dose cohorts, and Part B gives two repeated doses to participants with COPD in a multiple-ascending dose format. The trial measures safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and early signs of clinical activity. Results will guide dose selection and safety profiling for future studies.

Who should consider this trial

Good fit: Ideal candidates are adults 35–75 years with documented COPD (post-bronchodilator FEV1/FVC < 0.70) and FEV1 ≥ 50% and < 80% predicted, with BMI 18–32 kg/m² and who meet other screening safety requirements.

Not a fit: Patients with more severe COPD (FEV1 < 50%), active infections, immunodeficiency, positive HIV/HBV/HCV serology, recent cancer, or other major uncontrolled comorbidities are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If BBT002 is safe and shows favorable pharmacology, it could lead to a new treatment option that may improve symptoms or lung function for people with moderate COPD.

How similar studies have performed: As a first-in-human Phase 1 dose-escalation program, BBT002's approach is early-stage and similar investigational COPD agents have shown mixed early results, so clinical benefit remains unproven.

Eligibility criteria

Inclusion Criteria:( A\&B)

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 B only)

1. Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70
2. FEV1 ≥ 50% and FEV1\<80% predicted at screening.

Exclusion Criteria:( part A \& B)

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 B 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

Where this trial is running

Hefei, Anhui and 10 other locations

• The Second Hospital of Anhui Medical Univesity — Hefei, Anhui, China (RECRUITING)
• The third affiliated hosptial of Guangzhou Medical University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Guangdong Medical University — Guangzhou, Guangdong, China (ACTIVE_NOT_RECRUITING)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (NOT_YET_RECRUITING)
• Qingyuan People's Hospital — Qingyuan, Guangdong, China (NOT_YET_RECRUITING)
• The First People's Hospital of Xinxiang City — Xinxiang, Henan, China (NOT_YET_RECRUITING)
• Yichang Central People's Hospital — Yichang, Hubei, China (NOT_YET_RECRUITING)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Chengdu fifth People's Hospital — Chengdu, Sichuang, China (NOT_YET_RECRUITING)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Tracy Ji, Study Director

Conditions: Chronic Obstructive Pulmonary Disease