Status:
UNKNOWN
A Study of MG-K10 in Subjects With Asthma
Lead Sponsor:
Shanghai Mabgeek Biotech.Co.Ltd
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 treatm...
Detailed 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 m...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05382910
Start Date
July 5 2022
End Date
June 20 2024
Last Update
August 21 2023
Active Locations (1)
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1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000