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

Sponsor

Topokine Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02647853

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nasolabial Folds Lipoatrophy Lipodystrophy	Drug: TAT4 Gel concentration A Drug: TAT4 Gel concentration B Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Adverse Event rates [21 days]
Adverse event rates by System Organ Class, as graded by current CTCAE

Secondary Outcome Measures

Plasma pharmacokinetics (Cmax) [Days 1 and 13]
Plasma pharmacokinetics (Tmax) [Days 1 and 13]
Plasma pharmacokinetics (AUC0-24) [Day 1 and 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Topokine Clinical Site	Cypress	California	United States	90630

Sponsors and Collaborators

Topokine Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Topokine Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT02647853

Other Study ID Numbers:

TAT4 A1

First Posted:

Jan 6, 2016

Last Update Posted:

Jan 6, 2016

Last Verified:

Jan 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Lipodystrophy

Study Results

No Results Posted as of Jan 6, 2016