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 - Trial NCT06385327
Access comprehensive clinical trial information for NCT06385327 through Pure Global AI's free database. This Phase 1 trial is sponsored by Assembly Biosciences and is currently Not yet recruiting. The study focuses on Recurrent Genital Herpes Simplex Type 2. Target enrollment is 146 participants.
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Study Focus
Sponsor & Location
Assembly Biosciences
Timeline & Enrollment
Phase 1
May 01, 2024
Jul 01, 2025
Primary Outcome
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results,Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366,Maximum Observed Plasma Concentration (Cmax) of ABI-5366,Time to Cmax (Tmax) of ABI-5366,Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366,Apparent Systemic Clearance (CL/F) of ABI-5366,Apparent Volume of Distribution (Vz/F) of ABI-5366,Dose normalized AUCs and Cmax of ABI-5366
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06385327
Non-Device Trial