A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IBI3002 Multiple Dosing in Healthy Participants and Patients With Asthma - A Randomized, Double-Blind, Placebo-Controlled, Dose-Ascending Study
This study is a randomized, double-blind, placebo-controlled multiple dose ascending study in healthy participants and patients with asthma. Healthy participants will be enrolled in Part A and patients with asthma in Part B: 1. Part A: 40 healthy participants will be enrolled across 5 cohorts, including dose levels of 150mg, 300mg, 600mg, 900mg SC, and 600mg IV. In each cohort, there will be 8 participants randomized at a ratio of 6:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 12 to 14 weeks. 2. Part B: 20 patients with asthma will be enrolled across 2 cohorts, including dose levels of 300mg and 900mg SC. In each cohort, there will be 10 participants randomized at a ratio of 8:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 16 weeks.
• (Part A and B) The body weight of men ≥ 50kg, and of women ≥ 45kg; Body mass index (BMI) between 18 and 32 kg/m2 (including cut-off values).
• (Part B) Diagnosed with asthma for at least 12 months according to the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
• (Part B) Evidence of airway reversibility within 5 years prior to screening, including but not limited to a positive bronchodilation test or bronchoprovocation test. If the historical results are not available, tests during the screening period will also be accepted.
• (Part B) Medium-high dose ICS therapy (defined as a daily dose of ≥250μg fluticasone propionate or equivalent ICS dose) in combination with at least one second controller \[e.g., LABA, LAMA, or LTRA for at least 3 months with a stable dose for at least 1 month prior to randomization.
• (Part B) Pre-BD FEV1 ≤ 80% of prediction.