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NCT06385327

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

A Phase 1a/1b, Blinded, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of ABI-5366 in Healthy Subjects and in Subjects Who Are Seropositive for Herpes Simplex Virus Type 2 With Recurrent Genital Herpes
Assembly Biosciences·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Recurrent Genital Herpes Simplex Type 2
Drug/Device/Intervention
ABI-5366
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Assembly Biosciences
Location
Auckland, New Zealand
Timeline & enrollment
Phase
Phase 1
Start date
May 01, 2024
End date
Jul 01, 2025
Enrollment
146 participants
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
Congenital herpesviral [herpes simplex] infectionAnogenital herpesviral [herpes simplex] infectionHerpesviral [herpes simplex] infectionsAnogenital herpesviral infection, unspecifiedHerpesviral infection, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06385327
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.