A Study of MG-K10 in Subjects With Asthma

• Status: Not yet recruiting
• Trial end date: 2023-07-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Mabgeek Biotech.Co.Ltd

Criteria

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;