Phase 1 Study to Assess the Safety and Tolerability of TA... | NCT02647853

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

NCT02647853

Sponsor

Topokine Therapeutics, Inc.

Status

Completed

Last Update Posted

Jan 6, 2016Estimated

Enrollment

16Actual

Phase

Phase 1

Conditions

Nasolabial Folds
Lipoatrophy
Lipodystrophy

Interventions

TAT4 Gel concentration A
TAT4 Gel concentration B
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jan 3, 2016

First Submission Date that Met QC Criteria

Jan 5, 2016

First Posted Date

Jan 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2016

Last Update Posted Date

Jan 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAT4 Gel concentration A	Experimental	TAT4 Gel concentration A applied once daily to 50 cm2 for 14 days.	Drug: TAT4 Gel concentration A
TAT4 Gel concentration B	Experimental	TAT4 Gel concentration B applied once daily to 50 cm2 for 14 days.	Drug: TAT4 Gel concentration B
Placebo	Placebo Comparator	Placebo product once daily to 50 cm2 for 14 days.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAT4 Gel concentration A	Drug		TAT4 Gel concentration A
TAT4 Gel concentration B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Topokine Clinical Site		Cypress	California	90630	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008060	Lipodystrophy

Ancestor Terms

ID	Term
D012875	Skin Diseases, Metabolic
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D052439	Lipid Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided