This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of SHR-1139 injection in healthy subjects who receive a single subcutaneous injection or intravenous infusion of SHR-1139 injection, and in patients with moderate - to - severe plaque psoriasis who receive multiple subcutaneous injections of SHR-1139 injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
SHR-1139 injections.
SHR-1139 injections placebo
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Adverse events (AEs)
Time frame: About 365 days for moderate-to-severe plaque psoriasis subjects
Adverse events (AEs)
Time frame: About 295 days for healthy subjects.
Serious adverse events (SAEs)
Time frame: About 295 days for healthy subjects.
Serious adverse events (SAEs)
Time frame: About 365 days for moderate-to-severe plaque psoriasis subjects.
Serum concentration of SHR-1139
Time frame: About 253 days for healthy subjects.
Serum concentration of SHR-1139
Time frame: About 365 days for moderate-to-severe plaque psoriasis subjects.
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