A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma

Korábbi kezelés

• Any clinically important infections within 4 weeks before randomization
• Any major surgery within 3 months before randomized, or any surgical plan during the study, or any treatment that may affect the evaluation of the subjects considered by the investigator
• Any parasitic infections within 6 months before randomization
• Drug or alcohol abuse
• Participated in other clinical trials and used investigational drugs containing active ingredients within 4 weeks or 5 half-lives before screening

Más betegség

• Any clinically important pulmonary disease
• Any disease other than asthma that may affect lung function
• Any disease other than asthma related to elevation of eosinophils
• Any immunodeficiency disease
• Any clinically important serious cardiovascular diseases unstable or uncontrolled
• Uncontrolled Hypertension
• Uncontrolled Diabetes Mellitus
• Malignancy diagnosed within 5 years before randomization
• Positive infectious disease test
• Allergy history to any biologicsl or other agent that investigator think the subject should not participate in the study

Laborértékek

• Abnormal laboratory tests during screening and baseline
• Prolonged QTc interval or other clinical significant abnormal findings in ECG at screening that may cause safety risk to the subject

Egyéb

• Current smoker or smoking cessation for less than 6 months at screening, or smoking history ≥10 pack- years
• Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study
• Any other circumstance inappropriate for participating in the clinical trial considered by the investigator

• Male or female aged between 18 and 75 years (inclusive)
• Weight ≥ 40 kg
• Meet the diagnostic criteria for asthma and have a medical history of at least 1 year
• Treatment with a total daily dose of either medium or high dose inhaled glucocorticoids (ICS) for at least 6 months before screening, with a stable use for 3 months before randomization
• At least one additional maintenance asthma controller with stable use for at least 3 months before randomization
• At least 2 exacerbations within 12 months before screening
• No birth plan and must agree to take effective contraceptive methods
• Sign informed consent form voluntarily for the trial