Hepatitis D, Hepatitis Delta Virus
Conditions
Brief summary
This study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple-ascending doses (MAD) of ABI-6250 in healthy participants. Effect of food will also be evaluated in Part A.
Interventions
DRUGABI-6250
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)
DRUGPlacebo
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)
Sponsors
Assembly Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose normalized AUCs and Cmax of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints |
| Apparent Systemic Clearance (CL/F) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints |
| Apparent Volume of Distribution (Vz/F) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints |
| Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results | From enrollment to 10 days after the last dose, at pre-specified timepoints |
| Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints |
| Maximum Observed Plasma Concentration (Cmax) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints |
| Time to Cmax (Tmax) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints |
| Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of AUC between fasted and fed treatments | From enrollment to 10 days after the last dose, at pre-specified timepoints |
| Comparison of plasma AUC between fasted and fed treatments | From enrollment to 10 days after the last dose, at pre-specified timepoints |
Countries
New Zealand
Outcome results
None listed