A Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI3002 in Healthy Participants and Participants With Mild to Moderate Asthma
This is a single-center, randomized, double-blind, placebo-controlled, phase 1, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 in healthy participants and mild to moderate asthmatics. Subjects will be randomly assigned to different dosages of IBI3002 and matched placebo groups. The entire trial cycle includes a 4-week screening period, 1-day treatment period and 5-week follow-up period.
• Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures.
• Participants must be between 18 and 55 years old, inclusive.
• Participants must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive.
• Participants of childbearing potential and their partners should use highly effective methods of birth control during the study and until 6 months after the study.
• Participants with asthma must have:
‣ Documented physician diagnosis of asthma for at least 12 months prior to screening and confirmed by the investigator;
⁃ Elevated FeNO defined as ≥ 25ppb;
⁃ Documented and stable GINA 2023 recommended Step 1\
∙ 3 controller treatment (defined as ≤ 250μg fluticasone propionate dry powder formulation equivalent total daily dose of ICS, alone or in combination with LABA) for the last 3 months prior to screening;
⁃ Pre-BD FEV1 ≥ 60% of prediction and Post-BD FEV1/forced vital capacity (FVC) \> 70%.