Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 4:06 PM
Study NCT ID:
NCT05165550
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects
Sponsor:
Viriom
Organization:
Study Overview
Official Title:
A Phase 1, Double-blind, Placebo-controlled Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-02
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:
To assess the safety and tolerability of Elsulfavirine following administration of single oral ascending doses in HIV-negative, healthy subjects.
Detailed Description:
This study is a double-blind, placebo-controlled, outpatient study of single oral ascending doses of Elsulfavirine to evaluate the safety, tolerability, and pharmacokinetics of Elsulfavirine and its active metabolite VM-1500A in HIV-negative, healthy subjects. Eight (8) subjects (6 active, 2 placebo) per dose level will be enrolled. Within each of the three cohorts consisting of 8 subjects, 6 subjects each will receive single oral doses of Elsulfavirine at 20 mg, 40 mg, or 80 mg in an escalating manner, and 2 subjects will receive matching placebo.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: