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

NCT02647853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-01-06

No results posted yet for this study

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.

Conditions

  • Nasolabial Folds
  • Lipoatrophy
  • Lipodystrophy

Interventions

DRUG

TAT4 Gel concentration A

DRUG

TAT4 Gel concentration B

DRUG

Placebo

Sponsors & Collaborators

  • Topokine Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02647853 on ClinicalTrials.gov