A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics

Korábbi kezelés

• History of participating in a clinical trial within 1 month or 5 half-lives of the test drug (whichever is longer) prior to randomization, or those who are currently participating in a clinical trial.
• History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening or randomization.
• History of live or attenuated vaccination within 1 month prior to randomization, or those who plan to be vaccinated during the study.
• For asthmatics only: history of a life-threatening asthma attack that required mechanical ventilation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years prior to randomization.
• For asthmatics only: history of asthma worsen or exacerbation resulting in emergency room (ER) visits or overnight hospitalizations, or an increase in asthma maintenance therapy, or use of systemic glucocorticoids within the last 3 months prior to randomization.

Más betegség

• History of allergies to any components of IBI3002 or placebo.
• History of blood or needle sickness, or those who cannot tolerate venipuncture.

Egyéb

• Female participants who are pregnant or breastfeeding at screening or randomization.

• 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%.