drugset / Trial / NCT03710681

A Safety Study of Multiple Subcutaneous (s.c.) Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis

NCT03710681

Phase 1 Unknown 16 enrolled Jiangsu HengRui Medicine Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a multiple dose escalating and open labeled clinical trial to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple subcutaneous (s.c.) injections of SHR-1314 in adults with moderate-to-severe plaque psoriasis. The primary objective of this study is to investigate the safety and tolerability of multiple doses of subcutaneous SHR-1314 in subjects with moderate-to-severe plaque psoriasis. Secondary objectives are to determine the pharmacokinetics (PK) and immunogenicity profile of SHR-1314 in subjects with moderate-to-severe plaque psoriasis.

Timeline

Start
2018-08-02
Primary completion
2019-04-21
Completion
2019-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject vunakizumab Protein / enzyme biologic 160 mg Subcutaneous
Subject vunakizumab Protein / enzyme biologic 240 mg Subcutaneous

Indications