Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 8:23 AM
Study NCT ID:
NCT06050460
Status:
UNKNOWN
Last Update Posted:
2023-09-22
First Post:
2023-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SA55 Injection: a Potential Therapy for the Prevention and Treatment of COVID-19
Sponsor:
Sinovac Life Sciences Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: