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Completed

NCT Number: NCT06740474

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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)

Primary outcomes

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

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

  2. Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

  3. Maximum Observed Plasma Concentration (Cmax) of ABI-6250

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

  4. Time to Cmax (Tmax) of ABI-6250

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

  5. Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

  6. Apparent Systemic Clearance (CL/F) of ABI-6250

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

  7. Apparent Volume of Distribution (Vz/F) of ABI-6250

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

  8. Dose normalized AUCs and Cmax of ABI-6250

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

Secondary outcomes

  1. Comparison of plasma AUC between fasted and fed treatments

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

  2. Comparison of AUC between fasted and fed treatments

    Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints

Sponsors and collaborators

Lead sponsor

Assembly Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Dec 4, 2025

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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