A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2023-03-20
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assembly Biosciences

Criteria

Inclusion Criteria:

• Body mass index (BMI) between 18.0 and 30.0 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

• Agreement to comply with protocol-specified contraceptive requirements

Exclusion Criteria:

• Positive results for any of the following serology tests, HBsAg, hepatitis B core antibody (HBcAb IgM), hepatitis C virus antibody (HCV Ab), or HIV-1 or -2 antibody

• 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 2 months before Screening