Clinical trial NCT06944925: A Study of BBT002 in Healthy Volunteers (HVs) and in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Bambusa Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-04-25
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

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)

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

Primary outcomes:
measure: Number of participants with adverse events following single and multiple administration of BBT002
timeFrame: Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
measure: Number of participants with change in Laboratory assessments
timeFrame: Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
measure: Number of participants with change in vital sign measurements following dose administration.
timeFrame: Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
measure: Number of participants with change in physical examination following dose administration.
timeFrame: Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
measure: Number of participants with change in 12-lead ECG readings
timeFrame: Part A- Up to Day 141; Part B and C- Up to Day 169 post first dose administration
Secondary outcomes:
measure: PK parameters- maximum observed concentration (Cmax)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: PK parameters- Time for maximum observed Concentration (Tmax)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: PK parameters- Area under the curve (AUC)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: PK parameters- Volume of distribution (Vz)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: PK parameters- Total clearance (CL)
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: PK parameters- - Elimination Half-life (t1/2).
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
measure: The immunogenicity of BBT002 is measured as the number and percentage of subjects who develop Anti-Drug Antibodies (ADA).
timeFrame: At specified timepoints pre-dose and up to 169 days post first dose administration
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
affiliation: Bambusa Therapeutics, Inc.
name: Lisa Li
role: STUDY_DIRECTOR
References: