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

Phase 1Active Not RecruitingNCT06385327

Assembly Biosciences115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

115

Conditions

Recurrent Genital Herpes Simplex Type 2

Interventions

ABI-5366DRUG

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

ABI-5366 PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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.

Locations (15)

East Sydney Doctors

Darlinghurst, New South Wales, Australia

Canopy Clinical Sutherland

Miranda, New South Wales, Australia

Momentum Clinical Research

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: 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