The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
53
Shanghai Xuhui District Central Hospital
Shanghai, China
RECRUITINGIncidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Time frame: Approximately 1 years
Peak Plasma Concentration (Cmax)
PK (Pharmacokinetics)
Time frame: Approximately 1 years
Peak time(Tmax)
PK (Pharmacokinetics)
Time frame: Approximately 1 years
Area under the plasma concentration versus time curve (AUC)
PK (Pharmacokinetics)
Time frame: Approximately 1 years
half-life(T1/2)
PK (Pharmacokinetics)
Time frame: Approximately 1 years
Immunogenicity
ADA(Anti-drug antibody)
Time frame: Approximately 1 years
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