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

NCT06740474 | Completed Phase 1 DMC

• 1 other identifier: ABI-6250-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis Delta Virus; Hepatitis D

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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

Study Arms (6)

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

EXPERIMENTAL

Part A: SAD Cohorts 1-5, Placebo

PLACEBO COMPARATOR

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

EXPERIMENTAL

Drug: ABI-6250

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

PLACEBO COMPARATOR

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

EXPERIMENTAL

Part B: MAD Cohorts 1-4, Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ABI-6250 DRUG

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

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

Placebo DRUG

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

Part B: MAD Cohorts 1-4, Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assembly Biosciences: lead

Study Sites (1)

New Zealand Clinical Research

Auckland, New Zealand

Location

MeSH Terms

Conditions

Hepatitis D

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: January 31, 2025
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)