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NCT07288554
A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 68
Sponsor: Bambusa Therapeutics
Location: The Second Hospital of Anhui Medical Univesity Hefei Anhui
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).
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 ≥ 30% and FEV1\
Source: ClinicalTrials.gov (NCT07288554). StuddyBuddy aggregates publicly available trial information.