NCT04441918

Tolerability,Safety,Pharmacokinetic Profile and Immunogenicity of a Recombinant Humanized Anti-SARS-CoV-2 Monoclonal Antibody (JS016) for Injection in Chinese Health Subjects

A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetic Profile and Immunogenicity of JS016 (Anti-SARS-CoV-2 Monoclonal Antibody) Injection in Chinese Healthy Subjects After Intravenous Infusion of Single Dose

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 15 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injection in Chinese healthy subjects after intravenous infusion of single dose.Eligible patients will be injection JS016 (anti-SARS-CoV-2 monoclonal antibody)

Conditions

• COVID-19; and High Infection Risk of SARS-CoV-2

Interventions

Type	Name	Description
COMBINATION_PRODUCT	JS016 (anti-SARS-CoV-2 monoclonal antibody)	JS016 (anti-SARS-CoV-2 monoclonal antibody)

Timeline

• Start date: 2020-06-05
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2020-06-22
• Last updated: 2020-06-22

Locations

1 site across 1 country: China