Shanghai Mabgeek Biotech.Co.Ltd
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.
Asthma
MG-K10
Placebo
Phase 1
Phase 2
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.
Study Type : | Interventional |
Estimated Enrollment : | 180 participants |
Masking: | Quadruple |
Primary Purpose: | Treatment |
Official Title: | Phase Ib/II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Asthmatic Subjects |
Actual Study Start Date : | July 5, 2022 |
Estimated Primary Completion Date : | December 20, 2023 |
Estimated Study Completion Date : | June 20, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: MG-K10 Q2W Received MG-K10 300 mg subcutaneous injection every 2 weeks |
Drug: MG-K10 |
Experimental: MG-K10 Q4W Received MG-K10 300 mg subcutaneous injection every 4 weeks |
Drug: MG-K10 |
Placebo Comparator: Placebo The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks. |
Drug: Placebo |
Ages Eligible for Study: | 18 Years to 75 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000