A Study of MG-K10 in Subjects With Asthma

Phase Ib/II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Asthmatic Subjects

This study is a phase Ib/II clinical trial conducted in Chinese adult asthmatic subjects to evaluate the preliminary efficacy and safety of MG-K10 humanized monoclonal antibody injection in the treatment of asthma.

The study was conducted in two phases: the Phase Ib study focused on the safety and tolerability of MG-K10 in adult asthma subjects. Phase II study focused on the preliminary efficacy in adults with moderate to severe asthma.

Inclusion Criteria:

• Asthma diagnosed according to the 2021 version of the GINA guidelines for at least 1 year;
• 1 second forced expiratory volume (FEV1) before randomization before bronchodilator use The measured value is ≤80% of the normal predicted value;
• Must have experienced at least one severe acute asthma attack within 12 months outbreak event.
• Positive bronchodilator test
• Subjects and partners agree to take effective contraceptive measures from signing the Informed Consent Form (ICF) to 6 months after the end of treatment

Exclusion Criteria:

• Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function
• Subjects with malignant tumor within 5 years
• Received biologics with the same therapeutic purpose within 6 months prior to screening,
• Women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeeding during the study period;