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

NCT06698575 | Completed Phase 1 FDA Drug

• 1 other identifier: ABI-1179-101
• Study Type: interventional
• Target: 103
• Locations: 3 countries
• Sites: 18

Brief 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.

Conditions

Recurrent Genital Herpes Simplex Type 2

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Area Under the Plasma Concentration Time Curve, (AUC) of ABI-1179

  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

  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

  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

  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

  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

  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

  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.

  Up to 56 days after last dose.

Secondary Outcomes (12)

• SAD Cohorts: Comparison of Plasma AUC between fasted and fed treatments

  MAD Cohorts: At pre-specified time points from Days 8 to 36.

• SAD Cohorts: Comparison of plasma Cmax between fasted and fed treatments

  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

  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.

  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

  MAD Cohorts: At pre-specified time points from Days 8 to 36.

Study Arms (5)

Part A: SAD Cohorts 1-5, ABI-1179

EXPERIMENTAL

Single dose of ABI-1179 (tablet) in Part A for cohorts 1-5

Drug: ABI-1179; Drug: ABI-1179 Placebo

Part A:SAD Cohorts 1-5, Placebo

PLACEBO COMPARATOR

Single dose of matching placebo (tablet) in Part A for Cohorts 1-5

Drug: ABI-1179; Drug: ABI-1179 Placebo

Part A: (SAD) Fed Cohort 6 or 7, ABI-1179

EXPERIMENTAL

Single dose of ABI-1179 (tablet) in Part A for Cohort 6 or 7, food effect

Drug: ABI-1179; Drug: ABI-1179 Placebo

Part B: MAD Cohorts 1-4, ABI-1179

EXPERIMENTAL

Weekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose.

Drug: ABI-1179; Drug: ABI-1179 Placebo

Part B: MAD Cohorts 1-4 Placebo

PLACEBO COMPARATOR

Weekly dose of matching placebo (tablet) in Part B for Cohorts 1-4.

Drug: ABI-1179; Drug: ABI-1179 Placebo

Interventions

ABI-1179 DRUG

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

Part A: (SAD) Fed Cohort 6 or 7, ABI-1179; Part A: SAD Cohorts 1-5, ABI-1179; Part A:SAD Cohorts 1-5, Placebo; Part B: MAD Cohorts 1-4 Placebo; Part B: MAD Cohorts 1-4, ABI-1179

ABI-1179 Placebo DRUG

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

Part A: (SAD) Fed Cohort 6 or 7, ABI-1179; Part A: SAD Cohorts 1-5, ABI-1179; Part A:SAD Cohorts 1-5, Placebo; Part B: MAD Cohorts 1-4 Placebo; Part B: MAD Cohorts 1-4, ABI-1179

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assembly Biosciences: lead

Study Sites (18)

Alliance for Multispecialty Research

Kansas City, Missouri, 64114, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98104, United States

Location

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Location

East Sydney Doctors

Darlinghurst, Australia, 2010, Australia

Location

Royal Melbourne Hospital

Parkville, Australia, 3050, Australia

Location

Taylor Square Private Clinic

Surry Hills, Australia, 2010, Australia

Location

Momentum Clinical Research

Sydney, Australia, 2010, Australia

Location

Canopy Clinical Wollongong

Wollongong, Australia, 2500, Australia

Location

Momentum Sunshine

Melbourne, Au, 3021, Australia

Location

New Zealand Clinical Research

Auckland, New Zealand, 1010, New Zealand

Location

New Zealand Clinical Research

Christchurch, New Zealand, 8011, New Zealand

Location

Pacific Clinical Research Network

Nelson, New Zealand, 7011, New Zealand

Location

Momentum Palmerston North

Palmerston North, New Zealand, 4414, New Zealand

Location

Pacific Clinical Research Network

Rotorua, New Zealand, 3010, New Zealand

Location

Pacific Clinical Research Network

Upper Hutt, New Zealand, 5018, New Zealand

Location

Momentum Kapiti

Waikanae, New Zealand, 5036, New Zealand

Location

Pacific Clinical Research Network

Hamilton, New, 3200, New Zealand

Location

MeSH Terms

Conditions

Herpes Genitalis

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 21, 2024
• Study Start: December 8, 2024
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: March 23, 2026

Record last verified: 2025-08

Locations

US (4); AU (6); NZ (8)