Phase 1 Study to Assess the Safety and Tolerability of TAT4 Gel in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Gastrointestinal |
| Therapuetic Areas: | Endocrinology, Gastroenterology |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | December 2014 |
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.
the safety, tolerability, and plasma pharmacokinetics of two different concentrations of
TAT4 Gel administered once daily to 50 cm2 of skin for 14 days.
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
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