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Ethnobridging Study in Healthy Volunteers, Chinese and Japanese Subjects

NCT05298332 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-11-18

No results posted yet for this study

Summary

This is a single center, open-label, 3-Cohort, parallel, single-dose, study to evaluate the PK, safety, and tolerability of ATI-2173 50 mg administered orally in Japanese, Chinese, and Non-Asian healthy subjects incorporating a food effect analysis in Non-Asian healthy subjects.

Conditions

Interventions

DRUG

ATI-2173 50 mg

ATI-2173 is a phosphoramidate prodrug of the oral, non-chain terminating nucleoside analog clevudine being developed by Antios Therapeutics, Inc. for treatment of men and women with chronic hepatitis B (CHB)

Sponsors & Collaborators

  • Antios Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2022-08-22
Completion
2022-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05298332 on ClinicalTrials.gov