Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers

January 5, 2016 updated by: Topokine Therapeutics, Inc.

A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • Topokine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TAT4 Gel concentration A
TAT4 Gel concentration A applied once daily to 50 cm2 for 14 days.
Drug: TAT4 Gel concentration A
EXPERIMENTAL: TAT4 Gel concentration B
TAT4 Gel concentration B applied once daily to 50 cm2 for 14 days.
Drug: TAT4 Gel concentration B
PLACEBO_COMPARATOR: Placebo
Placebo product once daily to 50 cm2 for 14 days.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event rates
Time Frame: 21 days
Adverse event rates by System Organ Class, as graded by current CTCAE
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma pharmacokinetics (Cmax)
Time Frame: Days 1 and 13
Days 1 and 13
Plasma pharmacokinetics (Tmax)
Time Frame: Days 1 and 13
Days 1 and 13
Plasma pharmacokinetics (AUC0-24)
Time Frame: Day 1 and 13
Day 1 and 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topokine Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

January 3, 2016

First Submitted That Met QC Criteria

January 5, 2016

First Posted (ESTIMATE)

January 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAT4 A1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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