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A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection

NCT04248426 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-08-19

No results posted yet for this study

Summary

This is a double-blinded, randomized, placebo-controlled study of safety, tolerability, pharmacokinetics, and antiviral activity in both healthy volunteers and volunteers with chronic hepatitis B virus infection. Healthy volunteers will be administered either a single oral dose or multiple oral doses of ATI-2173 and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug. Volunteers with a diagnosis of chronic hepatitis B virus infection will be administered multiple oral doses of ATI-2173 and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

ATI-2173

ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth.

DRUG

ATI-2173 Placebo

ATI-2173 Placebo is used as an inactive comparator to ATI-2173. It will be dosed as a capsule by mouth.

Sponsors & Collaborators

  • Antios Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Douglas Mayers, MD · Antios Therapeutics, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-02-05
Primary Completion
2021-05-18
Completion
2021-05-18

Countries

  • Canada
  • Moldova
  • Ukraine

Study Locations

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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 NCT04248426 on ClinicalTrials.gov