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

Primary Purpose

Nasolabial Folds, Lipoatrophy, Lipodystrophy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TAT4 Gel concentration A
TAT4 Gel concentration B
Placebo
Sponsored by
Topokine Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasolabial Folds

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Topokine Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TAT4 Gel concentration A

TAT4 Gel concentration B

Placebo

Arm Description

TAT4 Gel concentration A applied once daily to 50 cm2 for 14 days.

TAT4 Gel concentration B applied once daily to 50 cm2 for 14 days.

Placebo product once daily to 50 cm2 for 14 days.

Outcomes

Primary Outcome Measures

Adverse Event rates
Adverse event rates by System Organ Class, as graded by current CTCAE

Secondary Outcome Measures

Plasma pharmacokinetics (Cmax)
Plasma pharmacokinetics (Tmax)
Plasma pharmacokinetics (AUC0-24)

Full Information

First Posted
January 3, 2016
Last Updated
January 5, 2016
Sponsor
Topokine Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02647853
Brief Title
Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
Official Title
A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Topokine Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasolabial Folds, Lipoatrophy, Lipodystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAT4 Gel concentration A
Arm Type
Experimental
Arm Description
TAT4 Gel concentration A applied once daily to 50 cm2 for 14 days.
Arm Title
TAT4 Gel concentration B
Arm Type
Experimental
Arm Description
TAT4 Gel concentration B applied once daily to 50 cm2 for 14 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo product once daily to 50 cm2 for 14 days.
Intervention Type
Drug
Intervention Name(s)
TAT4 Gel concentration A
Intervention Type
Drug
Intervention Name(s)
TAT4 Gel concentration B
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Adverse Event rates
Description
Adverse event rates by System Organ Class, as graded by current CTCAE
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Plasma pharmacokinetics (Cmax)
Time Frame
Days 1 and 13
Title
Plasma pharmacokinetics (Tmax)
Time Frame
Days 1 and 13
Title
Plasma pharmacokinetics (AUC0-24)
Time Frame
Day 1 and 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Topokine Clinical Site
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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