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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

NCT06698575 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-03-23

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-08
Primary Completion
2026-01-19
Completion
2026-01-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06698575 on ClinicalTrials.gov