NCT06048393

SA55 Novel Coronavirus Broad-spectrum Neutralizing Antibody Nasal Spray in Health People

A Phase I Clinical Study of Novel Coronavirus Broad-spectrum Neutralizing Antibody SA55 Nasal Spray in Healthy People

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerance, local drug content and neutralization activity in nasal cavity, systemic exposure level and immunogenicity of novel coronavirus broad-spectrum neutralizing antibody SA55 nasal spray.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	SA55 nasal spray	The novel coronavirus broad-spectrum neutralizing antibody SA55 nasal spray (SA55 nasal spray) is provided by Beijing Kexing Zhongwei Biotechnology Co., Ltd. The main component of this product is the novel coronavirus broad-spectrum neutralizing antibody, which is a colorless to pale yellow solution. Each milliliter contains 5mg of broad-spectrum neutralizing antibody against novel coronavirus. Excipients include histidine hydrochloride, arginine hydrochloride, histidine, sucrose, polysorbate 80 (II), hydroxypropyl cellulose, glycerol, and benzalkonium chloride (concentration 0.005%). 20 sprays per bottle, approximately 100 sprays per bottle μ L. Containing 0.5 mg of broad-spectrum neutralizing antibody against novel coronavirus.

Timeline

• Start date: 2023-05-31
• Primary completion: 2023-09-30
• Completion: 2023-10-31
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: China