Sensitization Study of ATx201 in Healthy Volunteers

NCT ID: NCT03375957

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2018-03-15

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.

Conditions

Sensitivity, Contact

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ATx201 2% Gel

Group Type: EXPERIMENTAL

ATx201

Intervention Type: DRUG

two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms

ATx201 4% Gel

Group Type: EXPERIMENTAL

ATx201

Intervention Type: DRUG

two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms

ATx201 Gel Placebo

Group Type: PLACEBO_COMPARATOR

ATx201 Placebo Gel

Intervention Type: DRUG

two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms

Interventions

ATx201

two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms

Intervention Type: DRUG

ATx201 Placebo Gel

two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UNION therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Prokocimer, MD

Role: STUDY_DIRECTOR

CMO

Locations

Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, United States

Countries

United States

Other Identifiers

ATx201-005

Identifier Type: -

Identifier Source: org_study_id