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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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;
Clareo Health | A Study of MG-K10 in Subjects With Asthma
