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
About this trial
This is an interventional treatment trial for Nasolabial Folds
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
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
NCT ID
NCT02647853
First Posted
January 3, 2016
Last Updated
January 5, 2016
Sponsor
Topokine Therapeutics, Inc.
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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