A Study to Evaluate the Irritation Potential of ATx201 in Healthy Volunteers

NCT03301870 | Completed Phase 1 FDA Drug

• 1 other identifier: ATx201-006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I single-site study to evaluate the irritation potential of topically applied ATx201 GEL, 2% and 4%, along with positive and negative control and placebo control (ATx201 GEL Placebo), in healthy human subjects on intact and abraded skin. Approximately thirty-six (36) healthy adult subjects will receive all the test articles to provide for 30 subjects to complete the study. The test articles will be applied to the upper back of the subjects during the study, and the placement of the test articles will be randomized. Abraded skin will be induced using sequential tape stripping.

Conditions

Irritation Potential of Topic Agent

Outcome Measures

Primary Outcomes (1)

• Cumulative Irritation Scores

  the sum of the combined Dermal response and Other Effects Score

  21 days

Secondary Outcomes (3)

• Time of combined Dermal response and Other Effects Score >=3

  21 days

• Incidence of Test Article Discontunation

  21 days

• Time to test article discontinuation

  21 days

Study Arms (9)

ATx201 GEL, 2% - intact skin

EXPERIMENTAL

ATx201 GEL, 2% applied intact skin

Drug: ATx201 Gel 2%

ATx201 GEL, 4% - intact skin

EXPERIMENTAL

ATx201 GEL, 4% applied to intact skin

Drug: ATx201 Gel 4%

ATx201 GEL, 2% - abraded skin

EXPERIMENTAL

ATx201 GEL, 2% applied to abraded skin

Drug: ATx201 Gel 2%

ATx201 GEL, 4% - abraded skin

EXPERIMENTAL

ATx201 GEL, 4% applied to abraded skin

Drug: ATx201 Gel 4%

ATx201 GEL Placebo - intact skin

PLACEBO COMPARATOR

ATx201 GEL Placebo applied to intact skin

Drug: ATx201 Placebo

ATx201 GEL Placebo - abraded skin

PLACEBO COMPARATOR

ATx201 GEL Placebo applied to abraded skin

Drug: ATx201 Placebo

Negative Irritant Control - intact skin

ACTIVE COMPARATOR

Negative (low) Irritant Control applied to intact skin

Drug: Negative Control

Negative Irritant Control - abraded skin

ACTIVE COMPARATOR

Negative (low) Irritant Control applied to abraded skin

Drug: Negative Control

Positive Irritant Control - intact skin

ACTIVE COMPARATOR

Positive (high) Irritant Control applied to intact skin

Drug: Positive Control

Interventions

ATx201 Gel 2% DRUG

2% active gel

ATx201 GEL, 2% - abraded skin; ATx201 GEL, 2% - intact skin

ATx201 Gel 4% DRUG

4% active gel

ATx201 GEL, 4% - abraded skin; ATx201 GEL, 4% - intact skin

Positive Control DRUG

Sodium Lauryl Sulfate 0.05% (w/v), USP in sterile, distilled Water for Injection, USP

Positive Irritant Control - intact skin

Negative Control DRUG

Water for Injection, USP

Negative Irritant Control - abraded skin; Negative Irritant Control - intact skin

ATx201 Placebo DRUG

matching placebo gel

ATx201 GEL Placebo - abraded skin; ATx201 GEL Placebo - intact skin

Eligibility Criteria

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

You may qualify if:

• Judged by the Investigator to have no health conditions that would impact the safety of the subject during participation.
• Body Mass Index (BMI) to be 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 a medically acceptable contraceptive method
• Willing to refrain from excessive consumption of sodium (\> 2,400 mg/day or \> 1 teaspoon equivalent/day) 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:

• any clinical investigational product within 30 days prior to Day 1 through EOS Visit
• recent or current medical condition that, in the opinion of the Investigator, might significantly affect an immunological response to topical ATx201 or compromise the safety of the subject.
• 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.
• use of any medication on a regular basis within 14 days prior to Day 1 through EOS that could change peripheral blood flow, with the exception of any prescribed birth control method or hormone replacement therapy.
• use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other than Vitamin A at normal dietary amounts) within 14 days prior to the Screening Visit through EOS Visit.
• intending to start, stop, or change the dose of any prescription or over-the-counter (OTC) medication within 48 hours prior to Day 1 through EOS Visit.
• use of any prescription or OTC topical medications on the upper back within 30 days prior to Day 1 through EOS Visit.
• history of sensitivity/allergy to any ingredients found in the ATx201 formulation or has a history of adverse reactions to topical medications.
• significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex.
• history of significant skin conditions or disorders such as psoriasis, atopic dermatitis, etc.
• history of significant dermatologic cancers, for example, melanoma or squamous cell carcinoma.
• displays an obvious difference in skin color on the upper back or the presence of a skin anomaly such as a recent sunburn, scratch, scar tissue, tattoo, or coloration that would interfere with placement of test sites, their assessment, and their potential response to the study drug or that could compromise the safety of the subject.
• smoking or use of tobacco or nicotine delivery products within 14 days prior to Day 1 through EOS Visit.
• female who is pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study.
• history of drug or alcohol addiction or abuse within the past year.

Sponsors & Collaborators

• UNION therapeutics: lead

Study Sites (1)

Bio-Kinetic Clinical Applications, LLC

Springfield, Missouri, 65802, United States

Location

Study Officials

• Philippe Prokocimer, MD

  Sponsor CMO

  STUDY DIRECTOR

Study Design

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

Model Details: the assignment of the test articles to the test sites will be randomized. Each "arm" is a different patch of skin on the same study participant

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: October 4, 2017
• Primary Completion: November 6, 2017
• Study Completion: November 6, 2017
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)