RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-08
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06698575

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject has a body mass index (BMI) between ≥18.0 and \<32.0 kg/m2
  2. * In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
  3. * 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).
  4. * Agreement to comply with protocol-specified contraceptive requirements.
  1. * 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).
  2. * 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.
  3. * History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson Syndrome, urticaria, or multiple drug allergies.
  4. * History of persistent alcohol abuse or illicit drug abuse within 3 years prior to screening.
  5. * 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.

Contacts and Locations

Study Contact

Assembly Biosciences Assembly Biosciences
CONTACT
833-509-4583
clinicaltrials@assemblybioscience.com

Study Locations (Sites)

Alliance for Multispecialty Research
Kansas City, Missouri, 64114
United States
Rochester Clinical Research
Rochester, New York, 14609
United States
Seattle Clinical Research Center
Seattle, Washington, 98104
United States
University of Washington Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Assembly Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-08
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-12-08
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • ABI-1179, PK, Healthy Participants, HSV-2, Recurrent Genital Herpes

Additional Relevant MeSH Terms

  • Recurrent Genital Herpes Simplex Type 2