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A Study to Evaluate the Irritation Potential of ATx201 in Healthy Volunteers

NCT03301870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-01-16

No results posted yet for this study

Summary

This is a Phase I single-site study to evaluate the irritation potential of topically applied ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201 GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to complete the study. The test articles will be applied to the upper back of the subjects during the study, and the placement of the test articles will be randomized. Abraded skin will be induced using sequential tape stripping.

Conditions

  • Irritation Potential of Topic Agent

Interventions

DRUG

ATx201 Gel 2%

2% active gel

DRUG

ATx201 Gel 4%

4% active gel

DRUG

Positive Control

Sodium Lauryl Sulfate 0.05% (w/v), USP in sterile, distilled Water for Injection, USP

DRUG

Negative Control

Water for Injection, USP

DRUG

ATx201 Placebo

matching placebo gel

Sponsors & Collaborators

  • UNION therapeutics

    lead INDUSTRY

Principal Investigators

  • Philippe Prokocimer, MD · Sponsor CMO

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-04
Primary Completion
2017-11-06
Completion
2017-11-06
FDA Drug
Yes

Countries

  • United States

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 NCT03301870 on ClinicalTrials.gov