NCT04483375

Safety, Tolerability and Pharmacokinetics of SCTA01, an Anti-SARS-CoV-2 Monoclonal Antibody, in Healthy Chinese Subjects

A Randomized, Double-blinded, Placebo-controlled, Single Ascending Dose, Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics of SCTA01 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics of SCTA01(anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects.

Detailed description

This is a Phase 1, First-in-Human, Randomized, Double-blinded, Placebo-Controlled, Single Ascending Dose Study of SCTA01(Anti-SARS-CoV-2 monoclonal antibody) in Healthy Chinese Subjects. Dose escalation will be guided by a safety review of clinical signs and symptoms, adverse events (AEs), and laboratory results of the prior dose cohort. An Interim analysis will be performed after Day 28 post-dose for the last dose cohort for review.

Conditions

• Coronavirus Disease 2019(COVID-19)

Interventions

Type	Name	Description
BIOLOGICAL	SCTA01	recombinant humanized anti-SARS-CoV-2 monoclonal antibody
OTHER	Placebo	Placebo

Timeline

• Start date: 2020-07-24
• Primary completion: 2020-11-17
• Completion: 2020-11-17
• First posted: 2020-07-23
• Last updated: 2021-03-23

Locations

1 site across 1 country: China