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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02647853
Other study ID # TAT4 A1
Secondary ID
Status Completed
Phase Phase 1
First received January 3, 2016
Last updated January 5, 2016
Start date October 2014
Est. completion date December 2014

Study information

Verified date January 2016
Source Topokine Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This Phase 1, randomized, placebo-controlled, double-blind, healthy volunteer study tested the safety, tolerability, and plasma pharmacokinetics of two different concentrations of TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- Men and women 40-70 years old

- Healthy volunteers

- Provision of informed consent

Exclusion Criteria:

- History of skin hypersensitivity

- Abnormality on screening assessments

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
TAT4 Gel concentration A

TAT4 Gel concentration B

Placebo


Locations

Country Name City State
United States Topokine Clinical Site Cypress California

Sponsors (1)

Lead Sponsor Collaborator
Topokine Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Event rates Adverse event rates by System Organ Class, as graded by current CTCAE 21 days Yes
Secondary Plasma pharmacokinetics (Cmax) Days 1 and 13 No
Secondary Plasma pharmacokinetics (Tmax) Days 1 and 13 No
Secondary Plasma pharmacokinetics (AUC0-24) Day 1 and 13 No
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