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

Last updated: March 20, 2026
Sponsor: Assembly Biosciences
Overall Status: Completed

Phase

1

Condition

Genital Herpes

Herpes Simplex Infections

Treatment

ABI-1179

ABI-1179 Placebo

Clinical Study ID

NCT06698575
ABI-1179-101
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 atScreening 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 laboratoryresults.

  • Female subjects must be non-pregnant and have a negative serum pregnancy test atScreening and a negative urine pregnancy test at Day 1 (predose).

  • Agreement to comply with protocol-specified contraceptive requirements

Exclusion

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 theresults of the study, pose an additional risk in administering study drug to thesubject, 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 toscreening.

  • Has participated in a clinical study involving administration of either aninvestigational or a marketed drug within 30 days or 5 half-lives before screening,whatever is longer.

Study Design

Total Participants: 103
Treatment Group(s): 2
Primary Treatment: ABI-1179
Phase: 1
Study Start date:
December 08, 2024
Estimated Completion Date:
January 19, 2026

Connect with a study center

  • Momentum Sunshine

    Melbourne, Au 3021
    Australia

    Site Not Available

  • Momentum Sunshine

    Melbourne 2158177, Au 3021
    Australia

    Site Not Available

  • East Sydney Doctors

    Darlinghurst, Australia 2010
    Australia

    Site Not Available

  • East Sydney Doctors

    Darlinghurst 2169378, Australia 2010
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Australia 3050
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville 2153770, Australia 3050
    Australia

    Site Not Available

  • Taylor Square Private Clinic

    Surry Hills, Australia 2010
    Australia

    Site Not Available

  • Taylor Square Private Clinic

    Surry Hills 2147821, Australia 2010
    Australia

    Site Not Available

  • Momentum Clinical Research

    Sydney, Australia 2010
    Australia

    Site Not Available

  • Momentum Clinical Research

    Sydney 2147714, Australia 2010
    Australia

    Site Not Available

  • Canopy Clinical Wollongong

    Wollongong, Australia 2500
    Australia

    Site Not Available

  • Canopy Clinical Wollongong

    Wollongong 2171507, Australia 2500
    Australia

    Site Not Available

  • Pacific Clinical Research Network

    Hamilton, New 3200
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Hamilton 2190324, New 3200
    New Zealand

    Site Not Available

  • New Zealand Clinical Research

    Auckland, New Zealand 1010
    New Zealand

    Site Not Available

  • New Zealand Clinical Research

    Auckland 2193733, New Zealand 1010
    New Zealand

    Site Not Available

  • New Zealand Clinical Research

    Christchurch, New Zealand 8011
    New Zealand

    Site Not Available

  • New Zealand Clinical Research

    Christchurch 2192362, New Zealand 8011
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Nelson, New Zealand 7011
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Nelson 2186280, New Zealand 7011
    New Zealand

    Site Not Available

  • Momentum Palmerston North

    Palmerston North, New Zealand 4414
    New Zealand

    Site Not Available

  • Momentum Palmerston North

    Palmerston North 2185018, New Zealand 4414
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Rotorua, New Zealand 3010
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Rotorua 6241325, New Zealand 3010
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Upper Hutt, New Zealand 5018
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Upper Hutt 6244895, New Zealand 5018
    New Zealand

    Site Not Available

  • Momentum Kapiti

    Waikanae, New Zealand 5036
    New Zealand

    Site Not Available

  • Momentum Kapiti

    Waikanae 2180320, New Zealand 5036
    New Zealand

    Site Not Available

  • Alliance for Multispecialty Research

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Alliance for Multispecialty Research

    Kansas City 4393217, Missouri 4398678 64114
    United States

    Site Not Available

  • Rochester Clinical Research

    Rochester, New York 14609
    United States

    Site Not Available

  • Rochester Clinical Research

    Rochester 5134086, New York 5128638 14609
    United States

    Site Not Available

  • Seattle Clinical Research Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • University of Washington Virology Research Clinic

    Seattle, Washington 98104
    United States

    Site Not Available

  • Seattle Clinical Research Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

  • University of Washington Virology Research Clinic

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

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