protocolSection identificationModule nctId: NCT06385327, orgStudyIdInfo id: ABI-5366-101, briefTitle: 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Assembly Biosciences, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Recurrent Genital Herpes Simplex Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: ABI-5366, interventions name: ABI-5366 Placebo, outcomesModule primaryOutcomes measure: Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results, primaryOutcomes measure: Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366, primaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of ABI-5366, primaryOutcomes measure: Time to Cmax (Tmax) of ABI-5366, primaryOutcomes measure: Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366, primaryOutcomes measure: Apparent Systemic Clearance (CL/F) of ABI-5366, primaryOutcomes measure: Apparent Volume of Distribution (Vz/F) of ABI-5366, primaryOutcomes measure: Dose normalized AUCs and Cmax of ABI-5366, secondaryOutcomes measure: SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments, secondaryOutcomes measure: MAD Cohorts: If applicable, comparison of plasma PK profiles and parameters with and without loading doses, secondaryOutcomes measure: MAD Cohorts: Difference in viral shedding rate (number of anogenital swabs positive for HSV-2 DNA/total number of swabs) across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in mean and median HSV-2 DNA copies/mL for swab samples positive for HSV-2 DNA across treatments, secondaryOutcomes measure: 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), secondaryOutcomes measure: MAD Cohorts: Difference in number of shedding episodes during the swabbing period across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in duration of shedding episodes during the swabbing period across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in subclinical shedding rate (number of swabs positive for HSV-2 DNA in the absence of lesions/total number of swabs in the absence of lesions) across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in lesion rate during the swabbing period across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in lesion duration during the swabbing period across treatments, secondaryOutcomes measure: MAD Cohorts: Difference in recurrence rate (number of reappearances of lesions during the swabbing period/total days assessed) across treatments, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: New Zealand Clinical Research, city: Auckland, country: New Zealand, contacts name: Study Principal Investigator, role: CONTACT, geoPoint lat: -36.84853, lon: 174.76349, hasResults: False