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

March 20, 2026 updated by: Assembly Biosciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Au
      • Melbourne, Au, Australia, 3021
        • Momentum Sunshine
    • Australia
      • Darlinghurst, Australia, Australia, 2010
        • East Sydney Doctors
      • Parkville, Australia, Australia, 3050
        • Royal Melbourne Hospital
      • Surry Hills, Australia, Australia, 2010
        • Taylor Square Private Clinic
      • Sydney, Australia, Australia, 2010
        • Momentum Clinical Research
      • Wollongong, Australia, Australia, 2500
        • Canopy Clinical Wollongong
  • New Zealand
    • New
      • Hamilton, New, New Zealand, 3200
        • Pacific Clinical Research Network
    • New Zealand
      • Auckland, New Zealand, New Zealand, 1010
        • New Zealand Clinical Research
      • Christchurch, New Zealand, New Zealand, 8011
        • New Zealand Clinical Research
      • Nelson, New Zealand, New Zealand, 7011
        • Pacific Clinical Research Network
      • Palmerston North, New Zealand, New Zealand, 4414
        • Momentum Palmerston North
      • Rotorua, New Zealand, New Zealand, 3010
        • Pacific Clinical Research Network
      • Upper Hutt, New Zealand, New Zealand, 5018
        • Pacific Clinical Research Network
      • Waikanae, New Zealand, New Zealand, 5036
        • Momentum Kapiti
  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Alliance for Multispecialty Research
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington Virology Research Clinic
      • Seattle, Washington, United States, 98104
        • Seattle Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Part A: Inclusion Criteria:

  • Subject has a body mass index (BMI) between ≥18.0 and <32.0 kg/m2
  • In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
  • Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day-1 or Day 1 (predose).
  • Agreement to comply with protocol-specified contraceptive requirements.

Part B: Inclusion Criteria:

  • Subject has a body mass index (BMI) between ≥18.0 and <32.0 kg/m2
  • Other than HSV infection, is in good health (as determined by the investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
  • Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1 (predose).
  • Agreement to comply with protocol-specified contraceptive requirements

Part A and B: Exclusion Criteria:

  • Current infection of human immunodeficiency virus (HIV), hepatitis B virus, (HBV), hepatitis C virus (HCV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV).
  • History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or condition known to interfere with the absorption /distribution/ elimination of drugs.
  • History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson Syndrome, urticaria, or multiple drug allergies.
  • History of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening.
  • Has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before screening, whatever is longer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: SAD Cohorts 1-5, ABI-1179
Single dose of ABI-1179 (tablet) in Part A for cohorts 1-5
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)
Placebo Comparator: Part A:SAD Cohorts 1-5, Placebo
Single dose of matching placebo (tablet) in Part A for Cohorts 1-5
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)
Experimental: Part A: (SAD) Fed Cohort 6 or 7, ABI-1179
Single dose of ABI-1179 (tablet) in Part A for Cohort 6 or 7, food effect
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)
Experimental: Part B: MAD Cohorts 1-4, ABI-1179
Weekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose.
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)
Placebo Comparator: Part B: MAD Cohorts 1-4 Placebo
Weekly dose of matching placebo (tablet) in Part B for Cohorts 1-4.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area Under the Plasma Concentration Time Curve, (AUC) of ABI-1179
Time Frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Maximum Observed Plasma Concentration (Cmax) of ABI-1179
Time Frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Time to Cmax (Tmax) of ABI-1179
Time Frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Apparent Terminal Elimination Half Life ( t 1/2) ABI-1179
Time Frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Apparent Systemic Clearance (CL/F) of ABI-1179
Time Frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Apparent Volume of Distribution (Vz/F) of ABI-1179
Time Frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Dose normalized AUCs and Cmax of ABI-1179
Time Frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AE's and abnormal laboratory results.
Time Frame: Up to 56 days after last dose.
Up to 56 days after last dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
MAD Cohorts: Difference in lesion duration during the swabbing period across treatments
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.
SAD Cohorts: Comparison of Plasma AUC between fasted and fed treatments
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.
SAD Cohorts: Comparison of plasma Cmax between fasted and fed treatments
Time Frame: SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing.
SAD Cohorts: before and at pre-specified timepoints up to 144 hours after dosing.
MAD Cohort: If applicable comparison of plasma AUC and Cmax with and without loading doses
Time Frame: MAD Cohorts At pre-specified timepoints from Days 8 to 36
MAD Cohorts At pre-specified timepoints from Days 8 to 36
MAD Cohorts: Difference in viral shedding rate (number of anogenital swabs positive for HSV-2 DNA/total number of swabs) across treatments.
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: in mean and median HSV-2 DNA copies/ml for swab samples positive for HSV-2 DNA across treatments
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: Difference in the proportion of swab samples with HSV-2 DNA>4log10 copies/mL across treatments (number of swabbing samples with HSV-2 DNA >4 log10 copies/mL / total number of swabs obtained).
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: Difference in number of shedding episodes during the swabbing period across treatments.
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: Difference in duration of shedding episodes during the swabbing period across treatments.
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: Difference in the subclinical shedding rate (number of swabs positive for HSV-2 DNA in the absence of lesions/total number of swabs in the absence of lesions) across treatments.
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: Difference in the lesion rate during the swabbing period across treatments.
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: Difference in the recurrence rate (number of reappearances of lesions during the swabbing period/total days assessed) across treatments.
Time Frame: MAD Cohorts: At pre-specified time points from Days 8 to 36.
MAD Cohorts: At pre-specified time points from Days 8 to 36.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assembly Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABI-1179-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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