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Completed

NCT Number: NCT05569941

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research

Grafton, Auckland, 1010, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABI-4334 Tablet

Drug

ABI-4334 Tablet

ABI-4334 Placebo

Drug

Placebo to ABI-4334 Tablet

Primary outcomes

  1. Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results

    Time frame: Up to Day 14

Secondary outcomes

  1. SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334

    Time frame: before and at pre-specified time points up to 144 hours after dosing

  2. SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334

    Time frame: before and at pre-specified time points up to 144 hours after dosing

  3. SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334

    Time frame: before and at pre-specified time points up to 144 hours after dosing

  4. SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334

    Time frame: before and at pre-specified time points up to 144 hours after dosing

  5. SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334

    Time frame: before and at pre-specified time points up to 144 hours after dosing

  6. SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334

    Time frame: before and at pre-specified time points up to 144 hours after dosing

  7. SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334

    Time frame: before and at pre-specified time points up to 144 hours after dosing

  8. SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334

    Time frame: before and at pre-specified time points up to 144 hours after dosing

  9. MAD Cohorts 1-2: AUC of ABI-4334

    Time frame: 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

  10. MAD Cohorts 1-2: Cmax of ABI-4334

    Time frame: 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

  11. MAD Cohorts 1-2: Tmax of ABI-4334

    Time frame: 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

  12. MAD Cohorts 1-2: t 1/2 of ABI-4334

    Time frame: 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

  13. MAD Cohorts 1-2: CL/F of ABI-4334

    Time frame: 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

  14. MAD Cohorts 1-2: Vz/F of ABI-4334

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study title

A Phase 1, Blinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics of Single and Multiple Ascending Doses of ABI-4334 in Healthy Subjects

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2022
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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