Sensitization Study of ATx201 in Healthy Volunteers

Overview

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.

Full Title of Study: “A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 17, 2018

Interventions

  • Drug: ATx201
    • two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
  • Drug: ATx201 Placebo Gel
    • two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms

Arms, Groups and Cohorts

  • Experimental: ATx201 2% Gel
  • Experimental: ATx201 4% Gel
  • Placebo Comparator: ATx201 Gel Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Dermal Response Score
    • Time Frame: 21 days
    • number of patients with a dermal response score of at least 2

Secondary Measures

  • Dermal Response and Effects Score
    • Time Frame: 21 days
    • number of patients with a dermal response and effects score of at least 3

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AntibioTx A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philippe Prokocimer, MD, Study Director, CMO

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