The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;
Subjects must have a Body Mass Index in the range of 19~26 kg/m2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;
Subjects must be in good health as judged by the investigator.
Reliable contraception must be assured during and for some time after the trial.
Subjects with a history of drug or other substance anaphylaxis;
Subjects with respiratory symptoms or abnormal respiratory tract;
Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;
Subjects with other diseases or factors with abnormal clinical manifestations;
Parallel
SV001
DrugSV001 ： single-dose
Placebo
DrugPlacebo ： single-dose
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Peak Plasma Concentration (Cmax)
PK (Pharmacokinetics)
Peak time（Tmax）
PK (Pharmacokinetics)
Area under the plasma concentration versus time curve (AUC)
PK (Pharmacokinetics)
half-life（T1/2）
PK (Pharmacokinetics)
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