JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects
Status:
Recruiting
Trial end date:
2021-10-30
Target enrollment:
Participant gender:
Summary
JS016-002-Ib/II is a randomized, double-blinded, placebo-controlled study, to investigate the
safety, PK profiles, preliminary efficacy and immunogenicity of intravenous Recombinant Human
Anti-SARS-CoV-2 Monoclonal Antibody (JS016) in participants with mild and moderate COVID-19
or of SARS-CoV-2 Asymptomatic Infection.
Three doses of JS016 are to be investigated, including 25mg/kg, 50mg/kg and 100mg/kg, given
as single dose of intravenous infusion. In total, 90 participants will be enrolled with 30
participants each for 25, 50 and 100mg/kg dose cohort at a ratio of 2:1 to receive
investigational product or placebo treatment, respectively.