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

NCT ID: NCT02647853

Last Updated: 2016-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Nasolabial Folds Lipoatrophy Lipodystrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TAT4 Gel concentration A

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

Group Type EXPERIMENTAL

TAT4 Gel concentration A

Intervention Type DRUG

TAT4 Gel concentration B

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

Group Type EXPERIMENTAL

TAT4 Gel concentration B

Intervention Type DRUG

Placebo

Placebo product once daily to 50 cm2 for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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TAT4 Gel concentration A

Intervention Type DRUG

TAT4 Gel concentration B

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Topokine Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Topokine Clinical Site

Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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TAT4 A1

Identifier Type: -

Identifier Source: org_study_id

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