Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-31 @ 10:23 PM
Study NCT ID:
NCT07184606
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone, a Concentrate for Solution Preparation for Infusion.
Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Organization:
Study Overview
Official Title:
Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone (N.F. Gamaleya NRCEM), a Concentrate for Solution Preparation for Infusion With Participation of Adult Healthy Volunteers.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
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:
A two-stage placebo-controlled open-label safety and pharmacokinetics study of the drug Fluorothiazinone, a concentrate for the preparation of an infusion solution, with participation of adult healthy volunteers.
Stage 1 - single administration; dose escalation will be carried out in sequential groups after evaluation of side effects data on day 7.
Stage 2 - course administration of the selected dose.
Total number of healthy replacement volunteers: 5.
Stage 1 - single administration; dose escalation will be carried out in sequential groups after evaluation of side effects data on day 7.
Stage 2 - course administration of the selected dose.
Total number of healthy replacement volunteers: 5.
Detailed Description:
None
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?: