A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose of IBI3002 in Patients With Asthma - a Randomized, Double-Blind, Placebo-Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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, FeNO≥25ppb 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Aged between 18 and 65 years old (inclusive).

• Weight ≥40kg.

• Diagnosed with Asthma for ≥12 months in accordance with the Global Initiative for Asthma (GINA) and confirmed by the Investigator.

• Receiving inhaled treatment with or without inhaled corticosteroids (ICS), which has been stablized for ≥ 1 month and confirmed by the Investigator.

• FeNO ≥25ppb at screening and randomization.

• Elevated peripheral blood eosinophils, defined as ≥300/μL in within 6 months prior to screening; OR ≥150/μL at screening.

• Pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV) ≤ 80% of prediction.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Wensheng Zang
wensheng.zang@innoventbio.com
15210342569
Time Frame
Start Date: 2025-06-20
Estimated Completion Date: 2026-05-20
Participants
Target number of participants: 9
Treatments
Experimental: IBI3002 600mg SC
Participants with asthma will receive IBI3002 600mg SC
Experimental: IBI3002 150mg SC
Participants with asthma will receive IBI3002 150mg SC
Placebo_comparator: Placebo 4ml SC
Participants with asthma will receive Placebo 4ml SC
Placebo_comparator: Placebo 1ml SC
Participants with asthma will receive Placebo 1ml SC
Placebo_comparator: Placebo 2ml SC
Participants with asthma will receive Placebo 2ml SC
Experimental: IBI3002 300mg SC
Participants with asthma will receive IBI3002 300mg SC
Related Therapeutic Areas
Sponsors
Collaborators: Innovent Biologics (Suzhou) Co. Ltd.
Leads: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov

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