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
Launched by ASSEMBLY BIOSCIENCES · Nov 18, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called ABI-1179 for people who have recurrent genital herpes caused by the herpes simplex virus type 2 (HSV-2). The main goals of the study are to check how safe the medication is, how the body processes it, and how well it is tolerated by different groups of people. The trial includes two parts: Part A involves healthy volunteers, while Part B includes participants who have HSV-2 and experience recurring outbreaks. Researchers will also look at how food may affect the medication in healthy participants.
To be eligible for the trial, participants need to be between 18 and 65 years old and in good health, with a body mass index (BMI) within a certain range. Women must not be pregnant and agree to specific contraceptive measures during the study. Participants can expect to undergo health screenings and receive either a single or multiple doses of ABI-1179. It's important to note that people with certain health conditions, like HIV or significant allergies, cannot take part in the study. This trial is currently recruiting participants who meet these criteria.
Gender
ALL
Eligibility criteria
- Part A: Inclusion Criteria:
- • 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.
- Part B: Inclusion Criteria:
- • 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
- Part A and B: Exclusion Criteria:
- • Current infection of human immunodeficiency virus (HIV), hepatitis B virus, (HBV), hepatitis C virus (HCV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV).
- • 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.
About Assembly Biosciences
Assembly Biosciences is a leading biotechnology company dedicated to advancing innovative therapies for the treatment of viral infections, particularly hepatitis B (HBV). With a strong focus on developing novel antiviral agents and immunotherapy approaches, Assembly Biosciences leverages its proprietary technology platforms to address unmet medical needs in the field of infectious diseases. Committed to scientific excellence and patient-centric solutions, the company collaborates with research institutions and industry partners to accelerate the development of its pipeline assets, striving to improve the lives of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Parkville, , Australia
Christchurch, , New Zealand
Auckland, , New Zealand
Melbourne, Au, Australia
Darlinghurst, , Australia
Surry Hills, , Australia
Sydney, , Australia
Hamilton, New, New Zealand
Nelson, , New Zealand
Palmerston North, , New Zealand
Rotorua, , New Zealand
Upper Hutt, , New Zealand
Waikanae, , New Zealand
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported