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

NCT06048393 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-09-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ronghua Jin, M.D. · Beijing Ditan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-09-30
Completion
2023-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06048393 on ClinicalTrials.gov