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

NCT06740474 — Phase 1, Completed, 40 participants, Assembly Biosciences

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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

RegistryNCT06740474
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment40 (Actual)
SponsorAssembly Biosciences (Industry)
ConditionsHepatitis Delta Virus, Hepatitis D
InterventionsABI-6250, Placebo (Drug)
Datesstart 2025-01-31, primary completion 2025-07-08, completion 2025-07-08, first posted 2024-12-18, last updated 2025-12-04
Locations1 site in New Zealand

Related Papers Related Patents Related Grants Related Experts
All trials for Hepatitis Delta Virus All trials for Hepatitis D All trials of ABI-6250 All trials of Placebo

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Part A: SAD Cohorts 1-5, ABI-6250Experimental
Part A: SAD Cohorts 1-5, PlaceboPlacebo comparator
Part A: SAD Food Effect Cohort 6 or 7: ABI-6250ExperimentalDrug: ABI-6250
Part A: SAD Food Effect Cohort 6 (if applicable): PlaceboPlacebo comparator
Part B: MAD Cohorts 1-4, ABI-6250Experimental
Part B: MAD Cohorts 1-4, PlaceboPlacebo comparatorDrug: Placebo
  • ABI-6250 (Drug): Single dose (SAD) or once or twice daily dosing over 10 days (MAD)
  • Placebo (Drug): Single dose (SAD) or once or twice daily dosing over 10 days (MAD)

+Outcome measures

Primary outcomes

  • 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]
  • 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]
  • Dose normalized AUCs and Cmax of ABI-6250 [From enrollment to 10 days after the last dose, at pre-specified timepoints]

Secondary outcomes

  • Comparison of plasma AUC between fasted and fed treatments [From enrollment to 10 days after the last dose, at pre-specified timepoints]
  • Comparison of AUC between fasted and fed treatments [From enrollment to 10 days after the last dose, at pre-specified timepoints]

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
New Zealand Clinical ResearchAucklandNew Zealand