Chronic Hepatitis B
Conditions
Keywords
ABI-4334, PK, Healthy Subjects
Brief 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.
Interventions
DRUGABI-4334 Tablet
ABI-4334 Tablet
DRUGABI-4334 Placebo
Placebo to ABI-4334 Tablet
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 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results | Up to Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| MAD Cohorts 1-2: AUC of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: Cmax of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: Tmax of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: t 1/2 of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: CL/F of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: Vz/F of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
Countries
New Zealand
Outcome results
None listed