Evaluating BBT002 in Healthy Volunteers and COPD Patients

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

This study is testing a new drug called BBT002 in healthy volunteers and COPD patients to see how safe it is and how well it works.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Bambusa Therapeutics (industry)
• Locations: 1 site (Perth, Western Australia)
• Trial ID: NCT06944925 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and exploratory clinical activity of BBT002 through a randomized, blinded, placebo-controlled approach. It consists of three parts: Part A involves single ascending doses in healthy volunteers, Part B involves multiple ascending doses in healthy volunteers, and Part C involves multiple ascending doses in adult patients with Chronic Obstructive Pulmonary Disease (COPD). The study aims to gather comprehensive data on the drug's effects and safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults aged 35-75 with a documented history of COPD and specific lung function criteria.

Not a fit: Patients with significant comorbidities, such as autoimmune diseases or cancer, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for patients with Chronic Obstructive Pulmonary Disease.

How similar studies have performed: Other studies have shown promise with similar approaches in evaluating new treatments for COPD, but the specific drug BBT002 is novel.

Eligibility 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

Where this trial is running

Perth, Western Australia

• Linear Clinical Research — Perth, Western Australia, Australia (RECRUITING)

Study contacts

• Study coordinator: Lisa Li

Conditions: Chronic Obstructive Pulmonary Disease