Moderate-to-severe Plaque Psoriasis Clinical Trial
Official title:
Safety, Tolerability and Pharmacokinetics Studies Following Multiple Subcutaneous Injections of SHR-1314 in Adults With Moderate-to-severe Plaque Psoriasis
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.
16 subjects with 2 dose groups will be enrolled in the study, all of whom received the SHR-1314 without placebo control. There are 8 subjects in each cohort. The dose will be started at 160mg and will be escalated by following dose escalating rules. The primary endpoint is the safety and tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc. ;
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