A Phase I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
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• 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.
Locations
Other Locations
China
Shanghai Xuhui District Central Hospital
RECRUITING
Shanghai
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 53
Treatments
Experimental: SV001
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Shanghai Synvida Biotechnology Co.,Ltd.