Overview
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.
Description
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.
Eligibility
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;
