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CompletedNCT06698575Updated Mar 23, 2026

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

A Phase 1 interventional study of ABI-1179 and ABI-1179 Placebo in Recurrent Genital Herpes Simplex Type 2, sponsored by Assembly Biosciences. Completed at 18 sites in 3 countries. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by Assembly Biosciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

02

Conditions studied

  • Recurrent Genital Herpes Simplex Type 2

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Keywords

  • ABI-1179, PK, Healthy Participants, HSV-2, Recurrent Genital Herpes
03

In context

Herpes Genitalis

70 studies on the registry are indexed under Herpes Genitalis; 3 are open to participants now.

This study's enrollment of 103 is close to the median of 103 across 53 interventional studies indexed under Herpes Genitalis.

Browse Herpes Genitalis studies →

Lead sponsor

Assembly Biosciences is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
103 participants (actual)

Study arms

  • 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 · Drug: ABI-1179 Placebo

  • 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 · Drug: ABI-1179 Placebo

  • 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 · Drug: ABI-1179 Placebo

  • 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 · Drug: ABI-1179 Placebo

  • 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 · Drug: ABI-1179 Placebo

Interventions

  • DrugABI-1179

    Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)

  • DrugABI-1179 Placebo

    Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

07

Study locations

18 sites
  • Alliance for Multispecialty Research
    Kansas City, Missouri 64114, United States
  • Rochester Clinical Research
    Rochester, New York 14609, United States
  • Seattle Clinical Research Center
    Seattle, Washington 98104, United States
  • University of Washington Virology Research Clinic
    Seattle, Washington 98104, United States
  • East Sydney Doctors
    Darlinghurst, Australia 2010, Australia
  • Royal Melbourne Hospital
    Parkville, Australia 3050, Australia
  • Taylor Square Private Clinic
    Surry Hills, Australia 2010, Australia
  • Momentum Clinical Research
    Sydney, Australia 2010, Australia
  • Canopy Clinical Wollongong
    Wollongong, Australia 2500, Australia
  • Momentum Sunshine
    Melbourne, Au 3021, Australia
  • New Zealand Clinical Research
    Auckland, New Zealand 1010, New Zealand
  • New Zealand Clinical Research
    Christchurch, New Zealand 8011, New Zealand
  • Pacific Clinical Research Network
    Nelson, New Zealand 7011, New Zealand
  • Momentum Palmerston North
    Palmerston North, New Zealand 4414, New Zealand
  • Pacific Clinical Research Network
    Rotorua, New Zealand 3010, New Zealand
  • Pacific Clinical Research Network
    Upper Hutt, New Zealand 5018, New Zealand
  • Momentum Kapiti
    Waikanae, New Zealand 5036, New Zealand
  • Pacific Clinical Research Network
    Hamilton, New 3200, New Zealand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06698575
Lead sponsor
Assembly Biosciences
Responsible party
Sponsor
First posted
Nov 21, 2024
Start date
Dec 8, 2024
Primary completion
Jan 19, 2026
Completion
Jan 19, 2026
Last update
Mar 23, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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