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

NCT06740474 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-04

No results posted yet for this study

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

Interventions

DRUG

ABI-6250

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-07-08
Completion
2025-07-08

Countries

  • New Zealand

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06740474 on ClinicalTrials.gov