Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
Phase 1
Completed
- Conditions
- Nasolabial FoldsLipoatrophyLipodystrophy
- Interventions
- Drug: TAT4 Gel concentration ADrug: TAT4 Gel concentration BDrug: Placebo
- Registration Number
- NCT02647853
- Lead Sponsor
- Topokine Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAT4 Gel concentration A TAT4 Gel concentration A TAT4 Gel concentration A applied once daily to 50 cm2 for 14 days. TAT4 Gel concentration B TAT4 Gel concentration B TAT4 Gel concentration B applied once daily to 50 cm2 for 14 days. Placebo Placebo Placebo product once daily to 50 cm2 for 14 days.
- Primary Outcome Measures
Name Time Method Adverse Event rates 21 days Adverse event rates by System Organ Class, as graded by current CTCAE
- Secondary Outcome Measures
Name Time Method Plasma pharmacokinetics (Cmax) Days 1 and 13 Plasma pharmacokinetics (AUC0-24) Day 1 and 13 Plasma pharmacokinetics (Tmax) Days 1 and 13
Trial Locations
- Locations (1)
Topokine Clinical Site
🇺🇸Cypress, California, United States