drugset / Trial / NCT03301870

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

NCT03301870

Phase 1 Completed 36 enrolled UNION therapeutics
RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start
2017-10-04
Primary completion
2017-11-06
Completion
2017-11-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ATx201 Unknown 2 % Topical
Subject ATx201 Unknown 4 % Topical
Comparator Sodium Lauryl Sulfate Small molecule 0.05 % Topical

Indications

No indication recorded.