NCT06698575

A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes

A Phase 1a/1b, Blinded, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Single- and Multiple Ascending Doses of ABI-1179 in Healthy Subjects and in Subjects Who Are Seropositive for Herpes Simplex Virus Type 2 With Recurrent Genital Herpes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Assembly Biosciences · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 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.

Conditions

• Recurrent Genital Herpes Simplex Type 2

Interventions

Type	Name	Description
DRUG	ABI-1179	Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
DRUG	ABI-1179 Placebo	Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)

Timeline

• Start date: 2024-12-08
• Primary completion: 2026-01-19
• Completion: 2026-01-19
• First posted: 2024-11-21
• Last updated: 2026-03-23

Locations

18 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study