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A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel
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.
Details
| Lead sponsor | Topokine Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2014-10 |
| Completion | 2014-12 |
Conditions
- Nasolabial Folds
- Lipoatrophy
- Lipodystrophy
Interventions
- TAT4 Gel concentration A
- TAT4 Gel concentration B
- Placebo
Primary outcomes
- Adverse Event rates — 21 days
Adverse event rates by System Organ Class, as graded by current CTCAE
Countries
United States