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