NCT03301870

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

A Single-Site Study To Evaluate The Irritation Potential Of Topically Applied ATx201 In Healthy Human Volunteers on Intact and Abraded Skin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: UNION therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-10-04
• Primary completion: 2017-11-06
• Completion: 2017-11-06
• First posted: 2017-10-04
• Last updated: 2019-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study