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

Lipodystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647853
• Other study ID #: TAT4 A1
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2016
• Last updated: January 5, 2016
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Topokine Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lipoatrophy
• Lipodystrophy
• Nasolabial Folds

Intervention

Drug:
• TAT4 Gel concentration A

• TAT4 Gel concentration B

• Placebo

Locations

Country	Name	City	State
United States	Topokine Clinical Site	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Topokine Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event rates	Adverse event rates by System Organ Class, as graded by current CTCAE	21 days	Yes
Secondary	Plasma pharmacokinetics (Cmax)		Days 1 and 13	No
Secondary	Plasma pharmacokinetics (Tmax)		Days 1 and 13	No
Secondary	Plasma pharmacokinetics (AUC0-24)		Day 1 and 13	No