Assessing the safety and effects of ABI-6250 in healthy individuals
A Phase 1a, Blinded, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of ABI-6250 in Healthy Subjects
This study tests the safety and effects of a new drug called ABI-6250 in healthy people to see how it works and how food impacts it, which could help in developing treatments for Hepatitis Delta Virus.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Assembly Biosciences Industry-sponsored |
| Locations | 1 site (Auckland) |
| Trial ID | NCT06740474 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of ABI-6250 through single and multiple ascending doses in healthy participants. It also examines how food intake affects the drug's performance. The study aims to gather essential data that could inform future research on treatments for Hepatitis Delta Virus.
Who should consider this trial
Good fit: Ideal candidates are healthy adults with a BMI between 18.0 and 32.0 kg/m2.
Not a fit: Patients with current infections of HIV, HBV, HCV, or HAV will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective treatments for patients with Hepatitis Delta Virus.
How similar studies have performed: While this approach is focused on a specific drug, similar studies assessing safety and pharmacokinetics of new treatments have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant has a body mass index (BMI) between ≥18.0 and \<32.0 kg/m2 and is in good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results. * Female participants 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). * Participants must agree to comply with protocol-specified contraceptive requirements. Exclusion Criteria: * Current infection of human immunodeficiency virus (HIV), hepatitis B virus, (HBV), hepatitis C virus (HCV) or acute hepatitis A virus (HAV). * 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
Auckland
- New Zealand Clinical Research — Auckland, 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.