A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Asthma
Status:
RECRUITING
Trial end date:
2026-05-20
Target enrollment:
Participant gender:
Summary
This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 multiple doses in participants with asthma. The study plans to enroll participants with asthma on stable inhaled treatment, FeNO25ppb at screening and randomization, elevated peripheral blood eosinophils and Pre-BD FEV1 80% of the prediction. The safety, tolerability, PK, immunogenicity and changes in PD and clinical characteristics of multiple doses of IBI3002 in asthma subjects will be evaluated.
The entire study includes the screening period (4 weeks before dosing), the treatment period (12 weeks), and the safety follow-up period (8 weeks).
The study plans to enroll 9 to 27 participants with asthma, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants will remain blind within the cohort.
Cohort 1: 150mg SC(IBI3002: placebo =2 :1); Cohort 2: 300mg SC(IBI3002: placebo =2 :1); Cohort 3: 600mg SC(IBI3002: placebo =2 :1);
The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.
Phase:
PHASE1
Details
Lead Sponsor:
The First Affiliated Hospital of Soochow University