Last updated: March 5, 2024
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Recruiting
Phase
1
Condition
Asthma
Treatment
Placebo
IBI3002
Clinical Study ID
NCT06213844
CIBI3002A101AU
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants must sign an Institutional Review Board (IRB) approved informed consentform 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 effectivemethods 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 toscreening 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 equivalenttotal daily dose of ICS, alone or in combination with LABA) for the last 3 monthsprior to screening;
- Pre-BD FEV1 ≥ 60% of prediction and Post-BD FEV1/forced vital capacity (FVC) > 70%.
Exclusion
Exclusion Criteria:
- History of allergies to any components of IBI3002 or placebo.
- History of blood or needle sickness, or those who cannot tolerate venipuncture.
- Female participants who are pregnant or breastfeeding at screening or randomization.
- History of participating in a clinical trial within 1 month or 5 half-lives of thetest drug (whichever is longer) prior to randomization, or those who are currentlyparticipating in a clinical trial.
- History of severe infection or significant injury within 6 months, or surgery within 3months, or any infection requiring systemic medication within 1 month prior toscreening or randomization.
- History of live or attenuated vaccination within 1 month prior to randomization, orthose who plan to be vaccinated during the study.
- For asthmatics only: history of a life-threatening asthma attack that requiredmechanical ventilation and/or was associated with hypercapnia, respiratory arrest orhypoxic seizures within the last 5 years prior to randomization.
- For asthmatics only: history of asthma worsen or exacerbation resulting in emergencyroom (ER) visits or overnight hospitalizations, or an increase in asthma maintenancetherapy, or use of systemic glucocorticoids within the last 3 months prior torandomization.
Study Design
Total Participants: 52
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
February 26, 2024
Estimated Completion Date:
February 15, 2025
Connect with a study center
Nucleus Network Pty Ltd
Melbourne, Victoria 3004
AustraliaActive - Recruiting
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