Sensitization Study of ATx201 in Healthy Volunteers

Sensitivity, Contact Clinical Trial

Official title:

A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375957
• Other study ID #: ATx201-005
• Status: Completed
• Phase: Phase 1
• Start date: January 8, 2018
• Est. completion date: March 15, 2018

Study information

• Verified date: May 2018
• Source: AntibioTx A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 15, 2018
• Est. primary completion date: February 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis, Contact
• Sensitivity, Contact

Intervention

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

Locations

Country	Name	City	State
United States	Bio-Kinetic Clinical Applications, LLC	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AntibioTx A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermal Response Score	number of patients with a dermal response score of at least 2	21 days
Secondary	Dermal Response and Effects Score	number of patients with a dermal response and effects score of at least 3	21 days