Sensitization Study of ATx201 in Healthy Volunteers
- Registration Number
- NCT03375957
- Lead Sponsor
- UNION therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATx201 Gel Placebo ATx201 Placebo Gel - ATx201 2% Gel ATx201 - ATx201 4% Gel ATx201 -
- Primary Outcome Measures
Name Time Method Dermal Response Score 21 days number of patients with a dermal response score of at least 2
- Secondary Outcome Measures
Name Time Method Dermal Response and Effects Score 21 days number of patients with a dermal response and effects score of at least 3
Trial Locations
- Locations (1)
Bio-Kinetic Clinical Applications, LLC
🇺🇸Springfield, Missouri, United States