Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study

Korábbi kezelés

• Bronchial thermoplasty or bronchial cryoablation were performed within 1 year prior to baseline.
• Acute asthma attacks requiring systemic glucocorticoid use for ≥3 days occurred within 1 month prior to baseline.
• Systemic glucocorticoids were used as maintenance therapy for the first 3 months of the baseline period.
• Acute episodes of life-threatening asthma occurred within 5 years prior to baseline.
• Allergen immunotherapy was administered 8 weeks prior to baseline.
• Participated in clinical trials of any drug or medical device within 12 weeks prior to screening.
• Severe trauma or major surgery in the 6 months prior to baseline.
• A history of infection requiring treatment with systemic anti-infective drugs in the 4 weeks prior to baseline.
• Parasitic infection was present in the 6 months prior to baseline.
• Alcohol consumption within 1 month prior to baseline.
• Those who had a history of blood donation within 4 weeks prior to baseline, or had significant blood loss, or had received a blood transfusion within 8 weeks.
• People who received live (attenuated) vaccine or viral vector vaccine within 8 weeks prior to the baseline period or planned to receive it during the trial.

Más betegség

• Combined with clinically significant lung disease other than asthma
• A combination of diseases other than asthma that may affect lung function
• Combined with other pulmonary or systemic diseases associated with eosinophil elevation, or other diseases associated with eosinophil elevation that the investigators believe need to be excluded.
• History of malignant tumor.
• Combined with serious other systemic diseases.
• Combined with immunodeficiency disease.
• At the time of screening, smokers were still smoking or had quit for less than 6 months, or had a smoking history of ≥10 pack-years.
• History of drug abuse and drug use within 1 year before screening.

Laborértékek

• Abnormal laboratory tests during screening or baseline. Screening or baseline ECG results were abnormal and clinically significant.

Egyéb

• Non-selective beta-blockers were used for the first 4 weeks of the baseline period.
• Researchers and relevant staff of research centres or others directly involved in programme implementation.
• The investigator considers that there are any circumstances that may cause subjects to be unable to complete the study or present a significant risk to subjects or other factors that may reduce the likelihood of enrollment.

• The age of signing the informed consent must be ≥12 years old and <18 years old, both male and female.
• Body weight ≥30 kg and BMI≥18 kg/m2.
• The clinical diagnosis was asthma for at least 6 months.
• Subjects receiving asthma maintenance therapy were required to maintain a stable dose for 4 weeks prior to baseline.
• FEV1/ estimated value of pre-BD before bronchodilator in screening period must be ≥40%.
• Screening period bronchial dilation test or bronchial excitation test positive.
• Informed consent was signed before the trial.
• Potentially fertile subjects voluntarily take appropriate contraceptive measures.