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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2016
• Main ID: NCT02647853
• Date of registration: 03/01/2016
• Prospective Registration: No
• Primary sponsor: Topokine Therapeutics, Inc.
• Public title: Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
• Scientific title: A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel
• Date of first enrolment: October 2014
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02647853
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lipodystrophy

Lipoatrophy

Nasolabial Folds

Intervention(s)

Drug: TAT4 Gel concentration B

Drug: Placebo

Drug: TAT4 Gel concentration A

Primary Outcome(s)

Adverse Event rates [Time Frame: 21 days]

Secondary Outcome(s)

Plasma pharmacokinetics (Cmax) [Time Frame: Days 1 and 13]

Plasma pharmacokinetics (Tmax) [Time Frame: Days 1 and 13]

Plasma pharmacokinetics (AUC0-24) [Time Frame: Day 1 and 13]

Secondary ID(s)

TAT4 A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors