A Phase 1a/1b, Blinded, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Single- and Multiple Ascending Doses of ABI-1179 in Healthy Subjects and in Subjects Who Are Seropositive for Herpes Simplex Virus Type 2 With Recurrent Genital Herpes
Status: Recruiting
Location: See all (18) 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-1179 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-1179 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
United States
Missouri
Alliance for Multispecialty Research
RECRUITING
Kansas City
New York
Rochester Clinical Research
RECRUITING
Rochester
Washington
Seattle Clinical Research Center
RECRUITING
Seattle
University of Washington Virology Research Clinic
RECRUITING
Seattle
Other Locations
Australia
East Sydney Doctors
RECRUITING
Darlinghurst
Momentum Sunshine
RECRUITING
Melbourne
Royal Melbourne Hospital
RECRUITING
Parkville
Taylor Square Private Clinic
RECRUITING
Surry Hills
Momentum Clinical Research
RECRUITING
Sydney
Canopy Clinical Wollongong
RECRUITING
Wollongong
New Zealand
New Zealand Clinical Research
RECRUITING
Auckland
New Zealand Clinical Research
RECRUITING
Christchurch
Pacific Clinical Research Network
RECRUITING
Hamilton
Pacific Clinical Research Network
RECRUITING
Nelson
Momentum Palmerston North
RECRUITING
Palmerston North
Pacific Clinical Research Network
RECRUITING
Rotorua
Pacific Clinical Research Network
RECRUITING
Upper Hutt
Momentum Kapiti
RECRUITING
Waikanae
Contact Information
Primary
Assembly Biosciences Assembly Biosciences
clinicaltrials@assemblybio.com
833-509-4583
Time Frame
Start Date:2024-12-08
Estimated Completion Date:2025-12
Participants
Target number of participants:146
Treatments
Experimental: Part A: SAD Cohorts 1-5, ABI-1179
Single dose of ABI-1179 (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 or 7, ABI-1179
Single dose of ABI-1179 (tablet) in Part A for Cohort 6 or 7, food effect
Experimental: Part B: MAD Cohorts 1-4, ABI-1179
Weekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose.
Placebo_comparator: Part B: MAD Cohorts 1-4 Placebo
Weekly dose of matching placebo (tablet) in Part B for Cohorts 1-4.