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Sensitization Study of ATx201 in Healthy Volunteers

NCT03375957 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-05-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • UNION therapeutics

    lead INDUSTRY

Principal Investigators

  • Philippe Prokocimer, MD · CMO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2018-02-17
Completion
2018-03-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03375957 on ClinicalTrials.gov