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

PHASE1RecruitingINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

May 30, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Recurrent Genital Herpes Simplex Type 2
Interventions
DRUG

ABI-5366

Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)

DRUG

ABI-5366 Placebo

Once daily tablet dosing (SAD) or weekly or monthly tablet dosing over the 29-day treatment period (MAD)

Trial Locations (17)

1010

RECRUITING

New Zealand Clinical Research, Auckland

2010

RECRUITING

East Sydney Doctors, Darlinghurst

RECRUITING

Taylor Square Private Clinic, Surry Hills

RECRUITING

Momentum Clinical Research, Sydney

2100

RECRUITING

Canopy Beaches Clinical Research, Sydney

2228

RECRUITING

Canopy Clinical Sutherland, Miranda

2500

RECRUITING

Canopy Clinical Wollongong, Wollongong

3010

RECRUITING

Pacific Clinical Research Network - Rotorua, Rotorua

3021

RECRUITING

Momentum Sunshine, Melbourne

3050

RECRUITING

Royal Melbourne Hospital, Parkville

3200

RECRUITING

Pacific Clinical Research Network - Hamilton, Hamilton

4215

WITHDRAWN

Gold Coast Sexual Health Centre, Southport

4414

RECRUITING

Momentum Palmerston North, Palmerston North

5018

RECRUITING

Pacific Clinical Research Network - Wellington, Upper Hutt

5036

RECRUITING

Momentum Kapiti, Waikanae

7011

RECRUITING

Pacific Clinical Research Network - Tasman, Nelson

8011

RECRUITING

New Zealand Clinical Research Christchurch, Christchurch

Sponsors
All Listed Sponsors
lead

Assembly Biosciences

INDUSTRY

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 | Biotech Hunter | Biotech Hunter