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

Phase 1Active Not RecruitingNCT06698575

Assembly Biosciences146 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

146

Conditions

Recurrent Genital Herpes Simplex Type 2

Interventions

ABI-1179DRUG

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

ABI-1179 PlaceboDRUG

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

Locations (18)

Alliance for Multispecialty Research

Kansas City, Missouri, United States

Rochester Clinical Research

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AE's and abnormal laboratory results.

Data from ClinicalTrials.gov

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