Status:
COMPLETED
A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Healthy Participants
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 IBI...
Eligibility Criteria
Inclusion
- 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%.
Exclusion
- 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 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.
Key Trial Info
Start Date :
February 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06213844
Start Date
February 26 2024
End Date
September 11 2025
Last Update
November 21 2025
Active Locations (1)
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1
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 3004