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 26, 2025
Sponsor: Assembly Biosciences
Overall Status: Active - Recruiting

Phase

1

Condition

Herpes Simplex Infections

Genital Herpes

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: 146
Treatment Group(s): 2
Primary Treatment: ABI-1179
Phase: 1
Study Start date:
December 08, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Momentum Sunshine

    Melbourne, Au 3021
    Australia

    Site Not Available

  • East Sydney Doctors

    Darlinghurst, 2010
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, 3050
    Australia

    Site Not Available

  • Taylor Square Private Clinic

    Surry Hills, 2010
    Australia

    Site Not Available

  • Momentum Clinical Research

    Sydney, 2010
    Australia

    Site Not Available

  • Pacific Clinical Research Network

    Hamilton, New 3200
    New Zealand

    Site Not Available

  • New Zealand Clinical Research

    Auckland, 1010
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Nelson, 7011
    New Zealand

    Site Not Available

  • Momentum Palmerston North

    Palmerston North, 4414
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Rotorua, 3010
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network

    Upper Hutt, 5018
    New Zealand

    Site Not Available

  • Momentum Kapiti

    Waikanae, 5036
    New Zealand

    Site Not Available

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