Sensitization Study of ATx201 in Healthy Volunteers

A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers

This is a Phase I, single-site study to evaluate the sensitization potential of topically applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.

Study Overview

• Status: Completed
• Conditions: Sensitivity, Contact
• Intervention / Treatment: Drug: ATx201; Drug: ATx201 Placebo Gel

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Bio-Kinetic Clinical Applications, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Good general health
• Body Mass Index no less than 19.0 and no greater than 36.0 kg/m² (inclusive).
• Demonstrates a Fitzpatrick skin score of I - IV
• Female subjects must agree to use acceptable contraceptive methods from the Screening Visit through 90 days after the End of Study (EOS) Visit; or postmenopausal status with no menses for at least 1 year prior to the Screening Visit.
• Willing to refrain from excessive consumption of sodium in food or beverage 48 hours prior to Day 1 through EOS Visit.
• Willing to shower using the same non-medicated soap/cleansers, and abstain from excessive sun exposure (including tanning salons) from the Screening Visit through EOS Visit.

Exclusion Criteria:

• Reports a history of diabetes mellitus, clinically significant asthma (acceptable if no episode within 5 years prior to Day 1), or currently diagnosed with hypertension or circulatory disease.
• Reports use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other than Vitamin A at normal dietary amounts)
• Reports a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex.
• Reports a history of significant skin conditions or disorders such as psoriasis, atopic dermatitis, etc.
• Reports a history of significant dermatologic cancers.
• Displays an obvious difference in skin color between upper arms or upper back or the presence of a skin anomaly
• Reports smoking or use of tobacco or nicotine delivery products within 14 days prior to Day 1 through EOS Visit.
• Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
• A female who is pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study.
• Reports a history of drug or alcohol addiction or abuse within the past year.
• Reports having donated blood or plasma within 48 hours prior to Day 1 through EOS Visit.
• Subject exhibits excessive hair density on the upper arms or back such that patch adhesion could be compromised.
• Subject reports undergoing hair depilation (e.g. chemical, laser, physical) within 30 days prior to Day 1 through EOS Visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ATx201 2% Gel	Drug: ATx201; two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
EXPERIMENTAL: ATx201 4% Gel	Drug: ATx201; two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
PLACEBO_COMPARATOR: ATx201 Gel Placebo	Drug: ATx201 Placebo Gel; two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermal Response Score	number of patients with a dermal response score of at least 2	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermal Response and Effects Score	number of patients with a dermal response and effects score of at least 3	21 days

Collaborators and Investigators

• Sponsor: UNION therapeutics
• Investigators: Study Director: Philippe Prokocimer, MD, CMO

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 8, 2018
• Primary Completion (ACTUAL): February 17, 2018
• Study Completion (ACTUAL): March 15, 2018

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Dermatitis, Contact
• Other Study ID Numbers: ATx201-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No