Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385327
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-18
Brief Title:
A Study to Assess the Safety Pharmacokinetics and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes
Sponsor:
Assembly Biosciences
Organization:
Assembly Biosciences
Study Overview
Official Title:
A Phase 1a1b Blinded Placebo-Controlled Study of the Safety Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of ABI-5366 in Healthy Subjects and in Subjects Who Are Seropositive for Herpes Simplex Virus Type 2 With Recurrent Genital Herpes
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This study is designed to assess safety tolerability and pharmacokinetics PK of single ascending dose SAD of ABI-5366 in Part A in healthy participants and multiple-ascending doses MAD of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 HSV-2 with recurrent genital herpes Effect of food will also be evaluated in Part A
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None