A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants

Launched by ASSEMBLY BIOSCIENCES · Dec 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ABI-6250 to see how safe it is and how well it is tolerated by healthy individuals. The researchers will give participants either one dose or multiple doses of the drug and observe its effects. They will also look at how food affects the drug in the first part of the study. The goal is to gather important information that will help understand how the drug works in the body.

To join the trial, participants must be generally healthy adults aged between 18 and 65 years, with a body mass index (BMI) within a certain range. Women in the study must not be pregnant and agree to follow guidelines about birth control. However, people with certain health issues, such as active infections or serious allergies, cannot participate. If you join the study, you can expect close monitoring by medical professionals, and you will be contributing to important research that could help treat hepatitis D in the future.

Gender

ALL

Eligibility 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.