Sensitization Study of ATx201 in Healthy Volunteers

• ATx201 (Drug): two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
• ATx201 Placebo Gel (Drug): two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms

Primary outcomes

• Dermal Response Score [21 days]: number of patients with a dermal response score of at least 2

Secondary outcomes

• Dermal Response and Effects Score [21 days]: number of patients with a dermal response and effects score of at least 3

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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.

• Philippe Prokocimer, MD, Study director, CMO