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Clinical Trial Summary

In this first-in-humans dose escalation study, SA55 will be evaluated for safety, tolerability, and pharmacokinetics. The study is intended to enable future studies of SA55-injection's efficacy in preventing and treating COVID-19.


Clinical Trial Description

This is a Phase I, first time in human, randomised, double-blind, placebo-controlled, and dose escalation study. A Screening Period of up to 14 days (Day -14 through Day 0); A Treatment Period during which participants will be resident at the hospital from Day 0, 1 day before IMP administration (on Day 1) . A Follow up Period lasting 183 days after the IMP dose. The study will be conducted at a single study centre in Beijing, China. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06050460
Study type Interventional
Source Sinovac Biotech Co., Ltd
Contact Ronghua Jin
Phone 01084323059
Email ronghuajin@ccmu.edu.cn
Status Recruiting
Phase Phase 1
Start date June 15, 2023
Completion date December 30, 2023

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