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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-07-08

Brief Summary

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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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Detailed Description

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Conditions

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Hepatitis Delta Virus Hepatitis D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: SAD Cohorts 1-5, ABI-6250

Group Type EXPERIMENTAL

No interventions assigned to this group

Part A: SAD Cohorts 1-5, Placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Part A: SAD Food Effect Cohort 6 or 7: ABI-6250

Group Type EXPERIMENTAL

ABI-6250

Intervention Type DRUG

Single dose (SAD) or once or twice daily dosing over 10 days (MAD)

Part A: SAD Food Effect Cohort 6 (if applicable): Placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Part B: MAD Cohorts 1-4, ABI-6250

Group Type EXPERIMENTAL

No interventions assigned to this group

Part B: MAD Cohorts 1-4, Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose (SAD) or once or twice daily dosing over 10 days (MAD)

Interventions

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ABI-6250

Single dose (SAD) or once or twice daily dosing over 10 days (MAD)

Intervention Type DRUG

Placebo

Single dose (SAD) or once or twice daily dosing over 10 days (MAD)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes