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A Study of Two Different Formulations of 611 in Healthy Adult Subjects in China
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Summary
The main purpose of this study is to compare two different formulations (mixtures) of 611 in healthy participants. This study will compare how much of each formulation gets into the blood stream.
Official title: A Randomized, Open-label, Parallel-enrollment Pharmacokinetic Comparison Study of Two Formulations of Recombinant Anti-IL-4Rα Humanized Monoclonal Antibody Injection (611) Injected Subcutaneously in Healthy Adult Subjects in China
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-07
Completion Date
2026-01
Last Updated
2025-06-27
Healthy Volunteers
Yes
Conditions
Interventions
new formulations of 611
Subjects will receive new formulations of 611 300mg once subcutaneous injection on D1
existing formulations of 611
Subjects will receive existing formulations of 611 300mg once subcutaneous injection on D1
Locations (2)
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiangsheng, China
Shanghai General Hospital
Shanghai, China