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

NCT06385327 | Completed Phase 1

• 1 other identifier: ABI-5366-101
• Study Type: interventional
• Target: 115
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Recurrent Genital Herpes Simplex Type 2

Keywords

ABI-5366; PK; Healthy Participants; HSV-2; Recurrent Genital Herpes

Outcome Measures

Primary Outcomes (8)

• Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366

  SAD Cohorts: before and at pre-specified time points up to 168 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-5366

  SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing. MAD Cohorts: before and at pre-specified time points up to 8 hours after dosing.

• Time to Cmax (Tmax) of ABI-5366

  SAD Cohorts: before and at pre-specified time points up to 168 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) of ABI-5366

  SAD Cohorts: before and at pre-specified time points up to 168 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-5366

  SAD Cohorts: before and at pre-specified time points up to 168 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-5366

  SAD Cohorts: before and at pre-specified time points up to 168 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-5366

  SAD Cohorts: before and at pre-specified time points up to 168 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 AEs, and abnormal laboratory results

  Up to 98 days after last dose

Secondary Outcomes (11)

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

  SAD Cohorts: before and at pre-specified time points up to 168 hours after dosing.

• MAD Cohorts: If applicable, comparison of plasma PK profiles and parameters with and without loading doses

  MAD Cohorts: At pre-specified time points 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: Difference 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.

• MAD Cohorts: Difference in the proportion of swab samples with HSV-2 DNA >4 log10 copies/mL across treatments (number of swabbing samples with HSV-2 DNA >4 log10 copies/mL / total number of swabs obtained)

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

Study Arms (5)

Part A: SAD Cohorts 1-5, ABI-5366

EXPERIMENTAL

Single dose of ABI-5366 (tablet) in Part A for Cohorts 1-5

Drug: ABI-5366; Drug: ABI-5366 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-5366; Drug: ABI-5366 Placebo

Part A: SAD Fed Cohort 6, ABI-5366

EXPERIMENTAL

Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect

Drug: ABI-5366

Part B: MAD Cohorts 1-4 ABI-5366

EXPERIMENTAL

Weekly or monthly dose of ABI-5366 (tablet) in Part B for Cohorts 1-4. May have a loading dose.

Drug: ABI-5366; Drug: ABI-5366 Placebo

Part B: MAD Cohorts 1-4 Placebo

PLACEBO COMPARATOR

Weekly or monthly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose.

Drug: ABI-5366; Drug: ABI-5366 Placebo

Interventions

ABI-5366 DRUG

Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)

Part A: SAD Cohorts 1-5, ABI-5366; Part A: SAD Cohorts 1-5, Placebo; Part A: SAD Fed Cohort 6, ABI-5366; Part B: MAD Cohorts 1-4 ABI-5366; Part B: MAD Cohorts 1-4 Placebo

ABI-5366 Placebo DRUG

Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)

Part A: SAD Cohorts 1-5, ABI-5366; Part A: SAD Cohorts 1-5, Placebo; Part B: MAD Cohorts 1-4 ABI-5366; Part B: MAD Cohorts 1-4 Placebo

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 a 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, whichever is longer.

Sponsors & Collaborators

• Assembly Biosciences: lead

Study Sites (15)

East Sydney Doctors

Darlinghurst, New South Wales, 2010, Australia

Location

Canopy Clinical Sutherland

Miranda, New South Wales, 2228, Australia

Location

Momentum Clinical Research

Sydney, New South Wales, 2010, Australia

Location

Canopy Beaches Clinical Research

Sydney, New South Wales, 2100, Australia

Location

Canopy Clinical Wollongong

Wollongong, New South Wales, 2500, Australia

Location

Momentum Sunshine

Melbourne, Victoria, 3021, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

New Zealand Clinical Research

Auckland, 1010, New Zealand

Location

New Zealand Clinical Research Christchurch

Christchurch, 8011, New Zealand

Location

Pacific Clinical Research Network - Hamilton

Hamilton, 3200, New Zealand

Location

Pacific Clinical Research Network - Tasman

Nelson, 7011, New Zealand

Location

Momentum Palmerston North

Palmerston North, 4414, New Zealand

Location

Pacific Clinical Research Network - Rotorua

Rotorua, 3010, New Zealand

Location

Pacific Clinical Research Network - Wellington

Upper Hutt, 5018, New Zealand

Location

Momentum Kapiti

Waikanae, 5036, 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: April 18, 2024
• First Posted: April 26, 2024
• Study Start: May 30, 2024
• Primary Completion: February 3, 2026
• Study Completion: February 3, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (8); AU (7)