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NCT06944925 | NOT YET RECRUITING | Chronic Obstructive Pulmonary Disease

A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:

Bambusa Therapeutics

Brief Summary:

This study is a randomized, blinded, placebo-controlled single (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and exploratory clinical activity of BBT002 in healthy volunteers (HVs) and in adult patients with Chronic Obstructive Pulmonary Disease (COPD).

Condition or disease

Chronic Obstructive Pulmonary Disease

Intervention/treatment

BBT002

Placebo

Phase

PHASE1

Detailed Description:

The study consists of three parts: * 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)

Study Type : INTERVENTIONAL
Estimated Enrollment : 98 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : A Randomized, Blinded, Placebo-controlled, Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics and Clinical Activity of BBT002 in HVs and COPD Patients
Actual Study Start Date : 2025-05-08
Estimated Primary Completion Date : 2026-10-31
Estimated Study Completion Date : 2027-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Key Inclusion Criteria (Parts A, B, C)
  • 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 C only)
  • 1. Documented history of COPD with a post-bronchodilator FEV1/FVC \< 0.70
  • 2. FEV1 ≥ 30% and FEV1\<80% predicted at screening.
  • Key Exclusion Criteria for (Parts A, B, C)
  • 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 C 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
    • A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)

    Location Details

    NCT06944925

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    Not yet recruiting

    Australia, Western Australia

    Linear Clinical Research

    Perth, Western Australia, Australia, 6009