Assessing the safety and effectiveness of ABI-5366 for 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-5366 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 drug called ABI-5366 to see if it is safe and effective for people with recurrent genital herpes.
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 | 8 sites (Miranda, New South Wales and 7 other locations) |
| Trial ID | NCT06385327 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of ABI-5366 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 will be monitored for safety and antiviral activity throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include healthy adults and individuals seropositive for HSV-2 with recurrent genital herpes who meet specific health criteria.
Not a fit: Patients with significant health issues other than HSV infection or those outside the specified BMI range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals suffering from recurrent genital herpes.
How similar studies have performed: While there have been studies on antiviral treatments for HSV-2, the specific approach of ABI-5366 is novel and has not been extensively tested.
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 a 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, whichever is longer.
Where this trial is running
Miranda, New South Wales and 7 other locations
- Sutherland Shire Clinical Research — Miranda, New South Wales, Australia (Recruiting)
- Momentum Clinical Research — Sydney, New South Wales, Australia (Recruiting)
- Northern Beaches Clinical Research — Sydney, New South Wales, Australia (Recruiting)
- Wollongong Clinical Research — Wollongong, New South Wales, Australia (Recruiting)
- Gold Coast Sexual Health Centre — Southport, Queensland, Australia (Recruiting)
- Royal Melbourne Hospital — Parkville, Victoria, Australia (Recruiting)
- New Zealand Clinical Research — Auckland, New Zealand (Recruiting)
- New Zealand Clinical Research Christchurch — Christchurch, New Zealand (Recruiting)
Study contacts
- Study coordinator: Assembly Biosciences
- Email: clinicaltrials@assemblybio.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.