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

December 2, 2025 updated by: Assembly Biosciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • New Zealand Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A: SAD Cohorts 1-5, ABI-6250
Drug: ABI-6250
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)
Placebo Comparator: Part A: SAD Cohorts 1-5, Placebo
Drug: Placebo
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)
Placebo Comparator: Part A: SAD Food Effect Cohort 6 (if applicable): Placebo
Drug: Placebo
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)
Experimental: Part B: MAD Cohorts 1-4, ABI-6250
Drug: ABI-6250
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)
Placebo Comparator: Part B: MAD Cohorts 1-4, Placebo
Drug: Placebo
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)
Experimental: Part A: SAD Food Effect Cohort 6 or 7: ABI-6250
Drug: ABI-6250
Single dose (SAD) or once or twice daily dosing over 10 days (MAD)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
From enrollment to 10 days after the last dose, at pre-specified timepoints
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
From enrollment to 10 days after the last dose, at pre-specified timepoints
Maximum Observed Plasma Concentration (Cmax) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
From enrollment to 10 days after the last dose, at pre-specified timepoints
Time to Cmax (Tmax) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
From enrollment to 10 days after the last dose, at pre-specified timepoints
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
From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Systemic Clearance (CL/F) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Volume of Distribution (Vz/F) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
From enrollment to 10 days after the last dose, at pre-specified timepoints
Dose normalized AUCs and Cmax of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
From enrollment to 10 days after the last dose, at pre-specified timepoints

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Comparison of plasma AUC between fasted and fed treatments
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
From enrollment to 10 days after the last dose, at pre-specified timepoints
Comparison of AUC between fasted and fed treatments
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
From enrollment to 10 days after the last dose, at pre-specified timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assembly Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABI-6250-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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