A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital Herpes
NCT ID: NCT06698575
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
146 participants
INTERVENTIONAL
2024-12-08
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Part A: SAD Cohorts 1-5, ABI-1179
Single dose of ABI-1179 (tablet) in Part A for cohorts 1-5
ABI-1179
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
ABI-1179 Placebo
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
Part A:SAD Cohorts 1-5, Placebo
Single dose of matching placebo (tablet) in Part A for Cohorts 1-5
ABI-1179
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
ABI-1179 Placebo
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
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
ABI-1179
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
ABI-1179 Placebo
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
Part B: MAD Cohorts 1-4, ABI-1179
Weekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose.
ABI-1179
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
ABI-1179 Placebo
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
Part B: MAD Cohorts 1-4 Placebo
Weekly dose of matching placebo (tablet) in Part B for Cohorts 1-4.
ABI-1179
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
ABI-1179 Placebo
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
Interventions
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ABI-1179
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
ABI-1179 Placebo
Once daily tablet dosing (SAD), or weekly tablet dosing over 29 days (MAD)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or condition known to interfere with the absorption /distribution/ elimination of drugs.
* History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson Syndrome, urticaria, or multiple drug allergies.
* History of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening.
* Has participated in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 half-lives before screening, whatever is longer.
18 Years
60 Years
ALL
Yes
Sponsors
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Assembly Biosciences
INDUSTRY
Responsible Party
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Locations
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Alliance for Multispecialty Research
Kansas City, Missouri, United States
Rochester Clinical Research
Rochester, New York, United States
Seattle Clinical Research Center
Seattle, Washington, United States
University of Washington Virology Research Clinic
Seattle, Washington, United States
East Sydney Doctors
Darlinghurst, Australia, Australia
Royal Melbourne Hospital
Parkville, Australia, Australia
Taylor Square Private Clinic
Surry Hills, Australia, Australia
Momentum Clinical Research
Sydney, Australia, Australia
Canopy Clinical Wollongong
Wollongong, Australia, Australia
Momentum Sunshine
Melbourne, Au, Australia
New Zealand Clinical Research
Auckland, New Zealand, New Zealand
New Zealand Clinical Research
Christchurch, New Zealand, New Zealand
Pacific Clinical Research Network
Nelson, New Zealand, New Zealand
Momentum Palmerston North
Palmerston North, New Zealand, New Zealand
Pacific Clinical Research Network
Rotorua, New Zealand, New Zealand
Pacific Clinical Research Network
Upper Hutt, New Zealand, New Zealand
Momentum Kapiti
Waikanae, New Zealand, New Zealand
Pacific Clinical Research Network
Hamilton, New, New Zealand
Countries
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Other Identifiers
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ABI-1179-101
Identifier Type: -
Identifier Source: org_study_id
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