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A Study of MG-K10 Humanized Monoclonal Antibody Injection in Subjects With Atopic Dermatitis
Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Summary
This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.
Official title: A Phase II Clinical Study on the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-06-30
Completion Date
2026-04-29
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
MG-K10/Placebo
To ensure blinding, 4 mL of placebo will be administered subcutaneously at Weeks 4, 12 and 20., for a total of 3 doses.
MG-K10/Placebo
To ensure blinding,an additional 2 mL of placebo will be administered subcutaneously at Weeks 4, 8, 12, 16 and 20.
Locations (2)
Tower 5,No.34,Chunxiao Road No.122 Pudong District, Shanghai, 201203.p R. china
Shanghai, Shanghai Municipality, China
Hangzhou First People's Hospital
Zhejiang, 杭州, China