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
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
• Age of 18-65 years (HVs), 35-75 years (patients)
• Body mass index between 18-32 kg/m², capped at 120 kg
• Negative pregnancy tests for women of childbearing potential
• Willingness to refrain from alcohol consumption for 24 hours prior to each study visit
• Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers
• Adequate contraception use (for men and women of childbearing potential)
• No clinically significant abnormalities or history of relevant diseases
• Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70
• FEV1 ≥ 50% and FEV1\<80% predicted at screening.
Locations
Other Locations
China
Chengdu fifth People's Hospital
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital of Guangdong Medical University
ACTIVE_NOT_RECRUITING
Guangzhou
The third affiliated hosptial of Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
Zhejiang Provincial People's Hospital
NOT_YET_RECRUITING
Hangzhou
The Second Hospital of Anhui Medical Univesity
RECRUITING
Hefei
Jiangmen Central Hospital
NOT_YET_RECRUITING
Jiangmen
Jiangxi Provincial People's Hospital
NOT_YET_RECRUITING
Nanchang
Qingyuan People's Hospital
NOT_YET_RECRUITING
Qingyuan
The First People's Hospital of Xinxiang City
NOT_YET_RECRUITING
Xinxiang
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Yichang Central People's Hospital
NOT_YET_RECRUITING
Yichang
Contact Information
Primary
Tracy Ji, Study Director
tracy.ji@bambusatx.com
+86 18001322760
Time Frame
Start Date:2025-09-05
Estimated Completion Date:2027-05-30
Participants
Target number of participants:68
Treatments
Experimental: Part A Single Ascending Dose BBT002
A single dose of BBT002 will be administered in healthy volunteers
Experimental: Part B Multiple Ascending Dose BBT002
Two doses of BBT002 will be administered in patients with COPD.
Placebo_comparator: Part A Single Ascending Dose Placebo
A single dose of Placebo will be administered in healthy volunteers.
Placebo_comparator: Part B Multiple Ascending Dose Placebo
Two doses of Placebo will be administered in patients with COPD.