The First Affiliated Hospital of Soochow University
With
Innovent Biologics (Suzhou) Co. Ltd.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Aged between 18 and 65 years old (inclusive).
2. Weight ≥40kg.
3. Diagnosed with Asthma for ≥12 months in accordance with the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
4. Receiving inhaled treatment with or without inhaled corticosteroids (ICS), which has been stablized for ≥ 1 month and confirmed by the Investigator.
5. FeNO ≥25ppb at screening and randomization.
6. Elevated peripheral blood eosinophils, defined as ≥300/μL in within 6 months prior to screening; OR ≥150/μL at screening.
7. Pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV) ≤ 80% of prediction.
You may not be if
1. Co-exsiting diseases that may have an impact on the participant's own safety or participation in the study, in the opinion of the Investigator. Including 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.
2. A known history of active tuberculosis or clinically suspected manifestations of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); Or chest imaging suggests the existence of suspected evidence of tuberculosis. Those with positive T-SPOT.TB need to receive preventive anti-tuberculosis treatment from 4 weeks before the first administration until the end of the study.
3. The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value at screening or randomization.
4. Experience of life-threatening asthma attacks requiring mechanical ventilation and/or asthma attacks related to hypercapnia, respiratory failure or hypoxic epilepsy within the 5 years prior to randomization.
5. History of other lung diseases besides asthma, including but not limited to chronic obstructive pulmonary disease, interstitial lung disease, etc, in the opinion of the Investigator.
The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.
