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

Assembly Biosciences

Status and phase: Not yet enrolling; Phase 1

Conditions: Recurrent Genital Herpes Simplex Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06698575

ABI-1179-101

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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146 participants in 5 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: ABI-1179

Drug: ABI-1179 Placebo

Part A:SAD Cohorts 1-5, Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: ABI-1179

Drug: ABI-1179 Placebo

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

Experimental group

Description:

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

Treatment:

Drug: ABI-1179

Drug: ABI-1179 Placebo

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

Experimental group

Description:

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

Treatment:

Drug: ABI-1179

Drug: ABI-1179 Placebo

Part B: MAD Cohorts 1-4 Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: ABI-1179

Drug: ABI-1179 Placebo