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OpenTrials
Completed

NCT Number: NCT02647853

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

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.

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Key information

Conditions

Nasolabial Folds Lipid Metabolism Disorders Lipoatrophy Lipodystrophy Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Topokine Clinical Site

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAT4 Gel concentration A

Drug

TAT4 Gel concentration B

Drug

Placebo

Drug

Primary outcomes

  1. Adverse Event rates

    Time frame: 21 days

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

Secondary outcomes

  1. Plasma pharmacokinetics (Cmax)

    Time frame: Days 1 and 13

  2. Plasma pharmacokinetics (Tmax)

    Time frame: Days 1 and 13

  3. Plasma pharmacokinetics (AUC0-24)

    Time frame: Day 1 and 13

Sponsors and collaborators

Lead sponsor

Topokine Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2016
Registry last updated
Jan 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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