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
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:
• Subject has a body mass index (BMI) between ≥ 18.0 and \< 32.0 kg/m2
• In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
• Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1 or Day 1 (predose)
• Agreement to comply with protocol-specified contraceptive requirements
• Subject has a body mass index (BMI) between ≥ 18.0 and \< 32.0 kg/m2
• Other than HSV infection, is in good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
• Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1 (predose)
• Agreement to comply with protocol-specified contraceptive requirements
Locations
Other Locations
Australia
East Sydney Doctors
RECRUITING
Darlinghurst
Momentum Sunshine
RECRUITING
Melbourne
Canopy Clinical Sutherland
RECRUITING
Miranda
Royal Melbourne Hospital
RECRUITING
Parkville
Gold Coast Sexual Health Centre
WITHDRAWN
Southport
Taylor Square Private Clinic
RECRUITING
Surry Hills
Canopy Beaches Clinical Research
RECRUITING
Sydney
Momentum Clinical Research
RECRUITING
Sydney
Canopy Clinical Wollongong
RECRUITING
Wollongong
New Zealand
New Zealand Clinical Research
RECRUITING
Auckland
New Zealand Clinical Research Christchurch
RECRUITING
Christchurch
Pacific Clinical Research Network - Hamilton
RECRUITING
Hamilton
Pacific Clinical Research Network - Tasman
RECRUITING
Nelson
Momentum Palmerston North
RECRUITING
Palmerston North
Pacific Clinical Research Network - Rotorua
RECRUITING
Rotorua
Pacific Clinical Research Network - Wellington
RECRUITING
Upper Hutt
Momentum Kapiti
RECRUITING
Waikanae
Contact Information
Primary
Assembly Biosciences
clinicaltrials@assemblybio.com
833-509-4583
Time Frame
Start Date:2024-05-30
Estimated Completion Date:2025-12
Participants
Target number of participants:146
Treatments
Experimental: Part A: SAD Cohorts 1-5, ABI-5366
Single dose of ABI-5366 (tablet) in Part A for Cohorts 1-5
Placebo_comparator: Part A: SAD Cohorts 1-5, Placebo
Single dose of matching placebo (tablet) in Part A for Cohorts 1-5
Experimental: Part A: SAD Fed Cohort 6, ABI-5366
Single dose of ABI-5366 (tablet) in Part A for Cohort 6, food effect
Experimental: Part B: MAD Cohorts 1-4 ABI-5366
Weekly or monthly dose of ABI-5366 (tablet) in Part B for Cohorts 1-4. May have a loading dose.
Placebo_comparator: Part B: MAD Cohorts 1-4 Placebo
Weekly or monthly dose of matching placebo (tablet) in Part B for Cohorts 1-4. May have a loading dose.