Back to resultsSensitization Study of ATx201 in Healthy Volunteers
Primary Purpose
Sensitivity, Contact
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ATx201
ATx201 Placebo Gel
Sponsored by
About this trial
This is an interventional treatment trial for Sensitivity, Contact
Eligibility Criteria
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.
Sites / Locations
- Bio-Kinetic Clinical Applications, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ATx201 2% Gel
ATx201 4% Gel
ATx201 Gel Placebo
Arm Description
Outcomes
Primary Outcome Measures
Dermal Response Score
number of patients with a dermal response score of at least 2
Secondary Outcome Measures
Dermal Response and Effects Score
number of patients with a dermal response and effects score of at least 3
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03375957
Brief Title
Sensitization Study of ATx201 in Healthy Volunteers
Official Title
A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
February 17, 2018 (Actual)
Study Completion Date
March 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNION therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensitivity, Contact
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATx201 2% Gel
Arm Type
Experimental
Arm Title
ATx201 4% Gel
Arm Type
Experimental
Arm Title
ATx201 Gel Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ATx201
Intervention Description
two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
Intervention Type
Drug
Intervention Name(s)
ATx201 Placebo Gel
Intervention Description
two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms
Primary Outcome Measure Information:
Title
Dermal Response Score
Description
number of patients with a dermal response score of at least 2
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Dermal Response and Effects Score
Description
number of patients with a dermal response and effects score of at least 3
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Prokocimer, MD
Organizational Affiliation
CMO
Official's Role
Study Director
Facility Information:
Facility Name
Bio-Kinetic Clinical Applications, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Sensitization Study of ATx201 in Healthy Volunteers
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