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Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.

NCT04069689 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-09-19

No results posted yet for this study

Summary

This is a placebo-controlled, double-blind, 2-period study in 3 sequential groups of 8 healthy subjects each. The safety and pharmacokinetics of escalating single and multiple oral doses of EPX-100 will be assessed in fasting healthy subjects and following a high-fat meal.

Conditions

Interventions

DRUG

EPX-100 (Clemizole Hydrochloride)

EPX-100 (Clemizole Hydrochloride)

DRUG

Placebos

Placebo to match EPX-100

Sponsors & Collaborators

  • Epygenix

    lead INDUSTRY

Principal Investigators

  • Hahn-Jun Lee, Ph.D. · Epygenix Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-08-29
Primary Completion
2019-11-27
Completion
2019-11-27
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 NCT04069689 on ClinicalTrials.gov