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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.
Huanshan Hospital , Shanghai Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGHuanshan Hospital , Shanghai Fudan University
Shanghai, China
RECRUITINGIncidence and severity of Treatment-Emergent Adverse Events [Safety and tolerability]
Incidence and severity of adverse events, change from baseline in vital signs and 12-lead electrocardiogram.
Time frame: Baseline to 168 days after first dose administration
Incidence of development of Anti-drug Antibodies (ADAs) [Safety and Tolerability]
Incidence of development of Anti-drug Antibodies (ADAs) during the course of the study.
Time frame: Baseline to 168 days after first dose administration
Assessment of PK parameter
time to maximum concentration (tmax)
Time frame: Baseline to 168 days after first dose administration
Assessment of PK parameter
maximum concentration (Cmax)
Time frame: Baseline to 168 days after first dose administration
Assessment of PK parameter
area under curve (AUC0-14days)
Time frame: Baseline to 168 days after first dose administration
Assessment of development of Anti-drug Antibodies (ADAs)
Incidence of development of Anti-drug Antibodies (ADAs)
Time frame: Baseline to 168 days after first dose administration
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