Sensitization Study of ATx201 in Healthy Volunteers

NCT03375957 | Completed Phase 1 FDA Drug

• 1 other identifier: ATx201-005
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Dermal Response Score

  number of patients with a dermal response score of at least 2

  21 days

Secondary Outcomes (1)

• Dermal Response and Effects Score

  21 days

Study Arms (3)

ATx201 2% Gel

EXPERIMENTAL

Drug: ATx201

ATx201 4% Gel

EXPERIMENTAL

Drug: ATx201

ATx201 Gel Placebo

PLACEBO COMPARATOR

Drug: ATx201 Placebo Gel

Interventions

ATx201 DRUG

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

ATx201 2% Gel; ATx201 4% Gel

ATx201 Placebo Gel DRUG

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

ATx201 Gel Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (1)

Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, 65802, United States

Location

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Philippe Prokocimer, MD

  CMO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: January 8, 2018
• Primary Completion: February 17, 2018
• Study Completion: March 15, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)