Actively Recruiting
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-05-28
60
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body weight of at least 50 kg for men and 45 kg for women
- Body mass index (BMI) between 18 and 32 kg/m2 inclusive
- For asthma patients: diagnosed with asthma for at least 12 months confirmed by the investigator
- For asthma patients: evidence of airway reversibility within 5 years prior to screening or during screening
- For asthma patients: receiving medium to high dose inhaled corticosteroids plus at least one additional controller medication for at least 3 months with a stable dose for at least 1 month
- For asthma patients: pre-bronchodilator FEV1 less than or equal to 80% of predicted value
You will not qualify if you...
- Any disease that may affect participant safety or study participation as judged by the investigator, including mental disorders or diseases of central nervous, cardiovascular, digestive, respiratory, urinary, blood, or metabolic systems
- History or clinical suspicion of active tuberculosis, positive T-SPOT.TB test during screening, or signs of latent tuberculosis
- History of malignancy except for localized basal cell or squamous cell carcinoma of the skin that has been removed or cured
- For asthma patients: history of life-threatening asthma attack requiring mechanical ventilation or related to hypercapnia, respiratory failure, or hypoxic epilepsy within 5 years prior to screening
- For asthma patients: asthma worsening or exacerbation requiring emergency room visit, hospitalization, increased controller medications, or systemic glucocorticoid therapy within 3 months prior to screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
China-japan Friendship Hosipital
Beijing, Beijing Municipality, China, 100192
Actively Recruiting
Research Team
W
Wenjing Duan
CONTACT
M
Man Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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