Irritation and Sensitization Study of HP-5000 Topical System

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess skin irritation and sensitization for HP-5000 patch in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Noven Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Subject provides written informed consent prior to entering the study or undergoing any study procedures;

• Subject is a generally healthy male or female 18 to 65 years of age;

• Subject is considered to be healthy on the basis of medical history, physical examination, vital signs, normal electrocardiogram (ECG) and clinical laboratory test results.

Exclusion Criteria:

• Subject is pregnant or lactating, or females planning a pregnancy during the course of the trial;

• Subject has severe cardiac, renal or hepatic impairment;

• Subject has used any topical drugs at the patch application site within 72 hours prior to dosing.