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

Assembly Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Recurrent Genital Herpes Simplex Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06385327

ABI-5366-101

Details and patient eligibility

About

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.

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 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.

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-5366

Experimental group

Description:

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

Treatment:

Drug: ABI-5366 Placebo

Drug: ABI-5366

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-5366 Placebo

Drug: ABI-5366

Part A: SAD Fed Cohort 6, ABI-5366

Experimental group

Description:

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

Treatment:

Drug: ABI-5366

Part B: MAD Cohorts 1-4 ABI-5366

Experimental group

Description:

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

Treatment:

Drug: ABI-5366 Placebo

Drug: ABI-5366

Part B: MAD Cohorts 1-4 Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: ABI-5366 Placebo

Drug: ABI-5366