RecruitingPhase 1NCT07015749

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Asthma

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


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

12 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and tolerability of IBI3002, a new injectable medication, in adults with moderate to severe asthma that is not well controlled despite inhaler therapy — particularly in people whose asthma is driven by high levels of a type of immune cell called eosinophils. **You may be eligible if...** - You are between 18 and 65 years old and weigh at least 40 kg - You have had asthma for at least 12 months - Your asthma treatment has been stable for at least 1 month - You have elevated eosinophil levels or a high FeNO result (a marker of airway inflammation) - Your lung function (FEV1) is below 80% of normal **You may NOT be eligible if...** - You have other significant lung diseases (such as COPD) - You have had a life-threatening asthma attack requiring mechanical ventilation in the past 5 years - You have active or suspected tuberculosis - You have significant problems with your heart, kidneys, liver, or other major organ - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Participants with asthma will receive Placebo at the corresponding dose and dosing interval.

DRUGIBI3002

Participants with asthma will receive IBI3002 at the corresponding dose and dosing interval.


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT07015749


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