A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT06944925
Last Updated: 2025-05-14
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
98 participants
INTERVENTIONAL
2025-05-08
2027-03-31
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 (three repeated doses in HVs in sequential ascending dose cohorts, MAD in HVs part)
* Part C (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
Three doses of BBT002 will be administered in healthy volunteers.
BBT002
BBT002 will be administered.
Part C 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
Three doses of Placebo will be administered in healthy volunteers.
Placebo
Placebo will be administered.
Part C 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 ≥ 30% 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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Principal Investigators
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Lisa Li
Role: STUDY_DIRECTOR
Bambusa Therapeutics, Inc.
Locations
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Linear Clinical Research
Perth, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Lara Hatchuel, Dr
Role: primary
Other Identifiers
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BBT002-001
Identifier Type: -
Identifier Source: org_study_id
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