Clinical trial NCT06740474: A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatitis Delta Virus
Hepatitis D
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
measure: Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
measure: Maximum Observed Plasma Concentration (Cmax) of ABI-6250
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
measure: Time to Cmax (Tmax) of ABI-6250
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
measure: Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
measure: Apparent Systemic Clearance (CL/F) of ABI-6250
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
measure: Apparent Volume of Distribution (Vz/F) of ABI-6250
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
measure: Dose normalized AUCs and Cmax of ABI-6250
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Secondary outcomes:
measure: Comparison of plasma AUC between fasted and fed treatments
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
measure: Comparison of AUC between fasted and fed treatments
timeFrame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
References: