Status:
RECRUITING
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 patient...
Eligibility Criteria
Inclusion
- (Part A and B) The body weight of men ≥ 50kg, and of women ≥ 45kg; Body mass index (BMI) between 18 and 32 kg/m2 (including cut-off values).
- (Part B) Diagnosed with asthma for at least 12 months according to the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
- (Part B) Evidence of airway reversibility within 5 years prior to screening, including but not limited to a positive bronchodilation test or bronchoprovocation test. If the historical results are not available, tests during the screening period will also be accepted.
- (Part B) Medium-high dose ICS therapy (defined as a daily dose of ≥250μg fluticasone propionate or equivalent ICS dose) in combination with at least one second controller \[e.g., LABA, LAMA, or LTRA for at least 3 months with a stable dose for at least 1 month prior to randomization.
- (Part B) Pre-BD FEV1 ≤ 80% of prediction.
Exclusion
- (Part A and B) Diseases that have an impact on the participant's own safety or participation in the study as judged by the investigator. This includes, but not limited to, mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, or metabolic system.
- (Part A and B) Participants with known history of active tuberculosis or clinical suspicion of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or positive T-SPOT.TB during the screening period, or evidence of suspected tuberculosis on chest imaging, or any other clinical evidence of latent tuberculosis.
- (Part A and B) A history of malignancy, except for localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin that has been resected or cured.
- (Part B) History of a life-threatening asthma attack requiring mechanical ventilation, and/or an asthma attack related to hypercapnia, respiratory failure, or hypoxic epilepsy within 5 years prior to screening.
- (Part B) History of an asthma worsening or exacerbation that resulted in an visit to emergency room or hospitalization, or an increase in asthma controller, or requiring any systemic glucocorticoid therapy within 3 months prior to screening.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.
Key Trial Info
Start Date :
May 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 23 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06947408
Start Date
May 14 2025
End Date
April 23 2026
Last Update
May 28 2025
Active Locations (1)
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1
China-japan Friendship Hosipital
Beijing, Beijing Municipality, China, 100192