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

The study consists of two parts:

• Part A (single dose in HVs in sequential ascending dose cohorts, SAD in HVs part)
• Part B (two repeated doses in patients with COPD, MAD in patients part)

Inclusion criteria

( A&B)

• Age of 18-65 years (HVs), 35-75 years (patients)
• Body mass index between 18-32 kg/m², capped at 120 kg
• Negative pregnancy tests for women of childbearing potential
• Willingness to refrain from alcohol consumption for 24 hours prior to each study visit
• Non-smokers, healthy current smokers (≤5 cigarettes/day), or ex-smokers
• Adequate contraception use (for men and women of childbearing potential)
• No clinically significant abnormalities or history of relevant diseases

Key Inclusion Criteria (Part B only)

• Documented history of COPD with a post-bronchodilator FEV1/FVC < 0.70
• FEV1 ≥ 30% and FEV1<80% predicted at screening.

Exclusion criteria

( part A & B)

• Positive viral serology for human immunodeficiency virus (HlV), hepatitis C virus (HCV), or hepatitis B (HBV)
• Immunodeficiencies, autoimmune diseases, or cancer, history of conditions predisposing to infections
• History of major metabolic, dermatological, liver, kidney, hematological or other significant disorders
• Clinically relevant abnormal lab results, including low blood counts, liver enzymes, or abnormal kidney function
• Positive drug/alcohol tests or abnormal vital signs at screening or Day -1
• Abnormal Electrocardiogram(ECG) findings
• History of drug/alcohol abuse in the past 2 years
• History of severe allergic reactions or hypersensitivity

Key Exclusion Criteria for (Part B only)

• Current diagnosis of other significant pulmonary disease
• Significant or unstable cardiovascular diseases
• Recent clinically significant infection
• Inability to perform spirometry