BBT002 in healthy adults and adults with COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 ≥ 30% 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 it's running

• The Second Hospital of Anhui Medical Univesity
  Hefei, Anhui, China Recruiting
• The third affiliated hosptial of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Guangdong Medical University
  Guangzhou, Guangdong, China Recruiting
• Jiangmen Central Hospital
  Jiangmen, Guangdong, China Recruiting
• Qingyuan People's Hospital
  Qingyuan, Guangdong, China Recruiting
• The First People's Hospital of Xinxiang City
  Xinxiang, Henan, China Recruiting

Study contacts

• Study coordinator: Tracy Ji, Study Director
• Email: tracy.ji@bambusatx.com
• Phone: +86 18001322760

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.