A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 with Recurrent Genital Herpes

Last updated: February 12, 2025
Sponsor: Assembly Biosciences
Overall Status: Active - Recruiting

Phase

1

Condition

Herpes Simplex Infections

Genital Herpes

Treatment

ABI-5366

ABI-5366 Placebo

Clinical Study ID

NCT06385327
ABI-5366-101
  • 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-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 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 a condition known to interfere with theabsorption/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,whichever is longer.

Study Design

Total Participants: 146
Treatment Group(s): 2
Primary Treatment: ABI-5366
Phase: 1
Study Start date:
May 30, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Sutherland Shire Clinical Research

    Miranda, New South Wales 2228
    Australia

    Active - Recruiting

  • Momentum Clinical Research

    Sydney, New South Wales 2010
    Australia

    Active - Recruiting

  • Northern Beaches Clinical Research

    Sydney, New South Wales 2100
    Australia

    Active - Recruiting

  • Wollongong Clinical Research

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • Gold Coast Sexual Health Centre

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • New Zealand Clinical Research

    Auckland, 1010
    New Zealand

    Active - Recruiting

  • New Zealand Clinical Research Christchurch

    Christchurch, 8011
    New Zealand

    Active - Recruiting

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