Assessing ABI-1179 for treating recurrent genital herpes
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
This study is testing a new medication called ABI-1179 to see if it can safely help people with recurrent genital herpes feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Assembly Biosciences Industry-sponsored |
| Locations | 13 sites (Melbourne, Au and 12 other locations) |
| Trial ID | NCT06698575 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of ABI-1179 in two parts. Part A involves healthy participants receiving single ascending doses, while Part B focuses on individuals with recurrent genital herpes caused by HSV-2 receiving multiple ascending doses. The study also examines the effect of food on the drug's pharmacokinetics. Participants must meet specific health criteria and agree to contraceptive requirements.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals and those seropositive for HSV-2 with recurrent genital herpes who meet the study's health criteria.
Not a fit: Patients with severe health conditions unrelated to HSV-2 or those outside the specified BMI range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from recurrent genital herpes.
How similar studies have performed: Other studies have shown promise in developing treatments for HSV-2, but the specific approach of ABI-1179 is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Melbourne, Au and 12 other locations
- Momentum Sunshine — Melbourne, Au, Australia (Not_yet_recruiting)
- East Sydney Doctors — Darlinghurst, Australia (Not_yet_recruiting)
- Royal Melbourne Hospital — Parkville, Australia (Not_yet_recruiting)
- Taylor Square Private Clinic — Surry Hills, Australia (Not_yet_recruiting)
- Momentum Clinical Research — Sydney, Australia (Not_yet_recruiting)
- Pacific Clinical Research Network — Hamilton, New, New Zealand (Not_yet_recruiting)
- New Zealand Clinical Research — Auckland, New Zealand (Recruiting)
- New Zealand Clinical Research — Christchurch, New Zealand (Not_yet_recruiting)
- Pacific Clinical Research Network — Nelson, New Zealand (Not_yet_recruiting)
- Momentum Palmerston North — Palmerston North, New Zealand (Not_yet_recruiting)
- Pacific Clinical Research Network — Rotorua, New Zealand (Not_yet_recruiting)
- Pacific Clinical Research Network — Upper Hutt, New Zealand (Not_yet_recruiting)
- Momentum Kapiti — Waikanae, New Zealand (Not_yet_recruiting)
Study contacts
- Study coordinator: Assembly Biosciences Assembly Biosciences
- Email: clinicaltrials@assemblybioscience.com
- Phone: 833-509-4583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.