RecruitingPhase 1NCT06947408

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants

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


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

60 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, double-blind, placebo-controlled multiple dose ascending study in healthy participants and patients with asthma. Healthy participants will be enrolled in Part A and patients with asthma in Part B: 1. Part A: 40 healthy participants will be enrolled across 5 cohorts, including dose levels of 150mg, 300mg, 600mg, 900mg SC, and 600mg IV. In each cohort, there will be 8 participants randomized at a ratio of 6:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 12 to 14 weeks. 2. Part B: 20 patients with asthma will be enrolled across 2 cohorts, including dose levels of 300mg and 900mg SC. In each cohort, there will be 10 participants randomized at a ratio of 8:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 16 weeks.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing multiple doses of a new inhaled drug called IBI3002 in healthy people and in people with asthma, to evaluate its safety, how well it is tolerated, and how the body processes it. **You may be eligible if...** - You are between the appropriate age ranges for your group - Your body weight and BMI fall within the acceptable range (BMI 18–32 kg/m²) - For the asthma part: you have been diagnosed with asthma for at least 12 months - For the asthma part: your asthma is moderate-to-severe and not fully controlled - For the asthma part: you have evidence of reversible airway narrowing on lung function tests **You may NOT be eligible if...** - You have poorly controlled asthma requiring recent hospitalization - You have significant heart, liver, kidney, or other serious medical conditions - You are pregnant or breastfeeding - You have recently used other inhaled medications that could interfere with the study drug - You smoke or have recently quit smoking 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

Healthy participants and patients with asthma will receive matched placebo.

DRUGIBI3002

Healthy participants and patients with asthma will receive IBI3002 at the corresponding dose and dosing interval.


Locations(1)

China-japan Friendship Hosipital

Beijing, Beijing Municipality, China

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NCT06947408


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