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Completed

NCT Number: NCT04271592

A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults

This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.

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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

Auckland Clinical Studies

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.

Exclusion criteria

  • Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
  • History of or current persistent drug or alcohol abuse.

Treatment and study plan

ABI-H3733 Liquid Oral Dosage Form

Drug

ABI-H3733 liquid oral dosage form

ABI-H3733 Solid Oral Dosage Form

Drug

ABI-H3733 solid oral dosage form

Placebo to ABI-H3733 Liquid Oral Dosage Form

Drug

Placebo to ABI-H3733 liquid oral dosage form

Placebo to ABI-H3733 Solid Oral Dosage Form

Drug

Placebo to ABI-H3733 solid oral dosage form

Primary outcomes

  1. Number of Participants with One or More Adverse Events

    Time frame: Up to Day 10

  2. Number of Participants with One or More Related Adverse Events

    Time frame: Up to Day 10

  3. Number of Participants with One or More Severe (Grade ≥3) Adverse Events

    Time frame: Up to Day 10

Secondary outcomes

  1. SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

  2. SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

  3. SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

  4. SAD Cohorts 1-7: Apparent Terminal Elimination Half-life (t1/2) of ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

  5. SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

  6. SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

  7. MAD Cohorts 8-10: AUC of ABI-H3733

    Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5

  8. MAD Cohorts 8-10: Cmax Over the Dosing Interval of ABI-H3733

    Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5

  9. MAD Cohorts 8-10: Tmax of ABI-H3733

    Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5

  10. MAD Cohorts 8-10: t1/2 of ABI-H3733

    Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5

  11. Single Dose Cohorts 11-12: AUC of ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

  12. Single Dose Cohorts 11-12: Cmax of ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

  13. Single Dose Cohorts 11-12: Tmax of ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

  14. Single Dose Cohorts 11-12: t1/2 of ABI-H3733

    Time frame: before and at pre-specified time points up to 120 hours after dosing

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study title

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Escalation and Food Effect Study of ABI-H3733 in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Jan 27, 2021

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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