Actively Recruiting
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Asthma
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-11-19
12
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
I
Innovent Biologics (Suzhou) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 65 years old (inclusive).
- Weight 40 kg or more.
- Diagnosed with asthma for at least 12 months according to the Global Initiative for Asthma (GINA) and confirmed by the investigator.
- Receiving stable inhaled treatment with or without inhaled corticosteroids for at least 1 month.
- Fractional exhaled nitric oxide (FeNO) level of at least 25 ppb at screening and randomization.
- Elevated peripheral blood eosinophils: at least 300/µL within 6 months prior to screening or at least 150/µL at screening.
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) at or below 80% of the predicted value.
You will not qualify if you...
- Presence of other diseases that may affect safety or study participation, including mental disorders, or diseases of the central nervous, cardiovascular, digestive, respiratory, urinary, blood, or metabolic systems.
- History or suspected active tuberculosis, or chest imaging suggesting tuberculosis; positive T-SPOT.TB test requiring preventive treatment.
- Peripheral blood white blood cells or neutrophils below normal limits at screening or randomization.
- Life-threatening asthma attacks requiring mechanical ventilation or related to hypercapnia, respiratory failure, or hypoxic epilepsy within the last 5 years.
- History of lung diseases other than asthma, such as chronic obstructive pulmonary disease or interstitial lung disease, as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
W
Wensheng Zang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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