A Study of BBT002 in Healthy Volunteers (HVs) and in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT07288554
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
68 participants
INTERVENTIONAL
2025-09-05
2027-05-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Part A Single Ascending Dose BBT002
A single dose of BBT002 will be administered in healthy volunteers
BBT002
BBT002 will be administered
Part B Multiple Ascending Dose BBT002
Two doses of BBT002 will be administered in patients with COPD.
BBT002
BBT002 will be administered
Part A Single Ascending Dose Placebo
A single dose of Placebo will be administered in healthy volunteers.
Placebo
Placebo will be administered
Part B Multiple Ascending Dose Placebo
Two doses of Placebo will be administered in patients with COPD.
Placebo
Placebo will be administered
Interventions
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BBT002
BBT002 will be administered
Placebo
Placebo will be administered
Eligibility Criteria
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Inclusion Criteria
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
1. Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70
2. FEV1 ≥ 50% and FEV1\<80% predicted at screening.
Exclusion Criteria
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
1. Current diagnosis of other significant pulmonary disease
2. Significant or unstable cardiovascular diseases
3. Recent clinically significant infection
4. Inability to perform spirometry
18 Years
75 Years
ALL
Yes
Sponsors
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Bambusa Therapeutics
INDUSTRY
Responsible Party
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Locations
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The Second Hospital of Anhui Medical Univesity
Hefei, Anhui, China
The third affiliated hosptial of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
The First People's Hospital of Xinxiang City
Xinxiang, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Chengdu fifth People's Hospital
Chengdu, Sichuang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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BBT002-002
Identifier Type: -
Identifier Source: org_study_id
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