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

Bambusa Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: BBT002

Study type: Interventional

Funder types: Industry

Identifiers

NCT06944925

BBT002-001

Details and patient eligibility

About

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).

Full 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)

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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98 participants in 6 patient groups, including a placebo group

Part A Single Ascending Dose BBT002

Experimental group

Description:

A single dose of BBT002 will be administered in healthy volunteers

Treatment:

Drug: BBT002

Part B Multiple Ascending Dose BBT002

Experimental group

Description:

Three doses of BBT002 will be administered in healthy volunteers.

Treatment:

Drug: BBT002

Part C Multiple Ascending Dose BBT002

Experimental group

Description:

Two doses of BBT002 will be administered in patients with COPD.

Treatment:

Drug: BBT002

Part A Single Ascending Dose Placebo

Placebo Comparator group

Description:

A single dose of Placebo will be administered in healthy volunteers.

Treatment:

Drug: Placebo

Part B Multiple Ascending Dose Placebo

Placebo Comparator group

Description:

Three doses of Placebo will be administered in healthy volunteers.

Treatment:

Drug: Placebo

Part C Multiple Ascending Dose Placebo

Placebo Comparator group

Description:

Two doses of Placebo will be administered in patients with COPD.

Treatment:

Drug: Placebo