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.
Full Title of Study: “A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Outcomes Assessor)
- Study Primary Completion Date: February 17, 2018
- Drug: ATx201
- two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
- Drug: ATx201 Placebo Gel
- two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms
Arms, Groups and Cohorts
- Experimental: ATx201 2% Gel
- Experimental: ATx201 4% Gel
- Placebo Comparator: ATx201 Gel Placebo
Clinical Trial Outcome Measures
- Dermal Response Score
- Time Frame: 21 days
- number of patients with a dermal response score of at least 2
- Dermal Response and Effects Score
- Time Frame: 21 days
- number of patients with a dermal response and effects score of at least 3
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- AntibioTx A/S
- Provider of Information About this Clinical Study
- Overall Official(s)
- Philippe Prokocimer, MD, Study Director, CMO
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