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

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: Completed
• Conditions: Hepatitis D; Hepatitis Delta Virus
• Intervention / Treatment: Drug: ABI-6250; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results	From enrollment to 10 days after the last dose, at pre-specified timepoints
Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250	From enrollment to 10 days after the last dose, at pre-specified timepoints
Maximum Observed Plasma Concentration (Cmax) of ABI-6250	From enrollment to 10 days after the last dose, at pre-specified timepoints
Time to Cmax (Tmax) of ABI-6250	From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250	From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Systemic Clearance (CL/F) of ABI-6250	From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Volume of Distribution (Vz/F) of ABI-6250	From enrollment to 10 days after the last dose, at pre-specified timepoints
Dose normalized AUCs and Cmax of ABI-6250	From enrollment to 10 days after the last dose, at pre-specified timepoints

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of plasma AUC between fasted and fed treatments	From enrollment to 10 days after the last dose, at pre-specified timepoints
Comparison of AUC between fasted and fed treatments	From enrollment to 10 days after the last dose, at pre-specified timepoints

Collaborators and Investigators

• Sponsor: Assembly Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Actual): July 8, 2025
• Study Completion (Actual): July 8, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepatitis; Hepatitis D
• Other Study ID 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