NCT02647853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

January 3, 2016

Last Update Submit

January 5, 2016

Conditions

Nasolabial FoldsLipoatrophyLipodystrophy

Outcome Measures

Primary Outcomes (1)

  • Adverse Event rates

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

    21 days

Secondary Outcomes (3)

  • Plasma pharmacokinetics (Cmax)

    Days 1 and 13

  • Plasma pharmacokinetics (Tmax)

    Days 1 and 13

  • Plasma pharmacokinetics (AUC0-24)

    Day 1 and 13

Study Arms (3)

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

TAT4 Gel concentration ADRUG
TAT4 Gel concentration A
TAT4 Gel concentration BDRUG
TAT4 Gel concentration B
PlaceboDRUG
Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 40-70 years old
  • Healthy volunteers
  • Provision of informed consent

You may not qualify if:

  • History of skin hypersensitivity
  • Abnormality on screening assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Topokine Clinical Site

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 6, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 6, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)