NCT02647853

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

A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Topokine Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	TAT4 Gel concentration A
DRUG	TAT4 Gel concentration B
DRUG	Placebo

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2016-01-06
• Last updated: 2016-01-06

Locations

1 site across 1 country: United States