Sensitization Study of ATx201 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

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

Conditions
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Sensitivity, Contact

Intervention / Treatment
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* Drug: ATx201
* Drug: ATx201 Placebo Gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATx201 2% Gel<br> | Drug: ATx201<br>* two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms<br>|
| Experimental: ATx201 4% Gel<br> | Drug: ATx201<br>* two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms<br>|
| Placebo Comparator: ATx201 Gel Placebo<br> | Drug: ATx201 Placebo Gel<br>* two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms<br>|

What is the study measuring?
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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 |