NCT06050460

SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19

A Phase I Clinical Trial to Evaluate the Safety, Tolerance and Pharmacokinetics of A Broad-Spectrum Neutralizing Antibodies SA55 Injection of COVID-19 in Healthy Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	SA55 Injection	Novel coronavirus broad-spectrum neutralizing antibody SA55 injection
OTHER	Placebo for SA55 injection	Placebo for Novel coronavirus broad-spectrum neutralizing antibody SA55 injection

Timeline

• Start date: 2023-06-15
• Primary completion: 2023-10-30
• Completion: 2023-12-30
• First posted: 2023-09-22
• Last updated: 2023-09-22

Locations

1 site across 1 country: China