drugset / Trial / NCT00455260
A Multi-Dose Study to Assess Tolerability, Safety and Pharmacology of hGH-ViaDerm™ System in Adults With GH-Deficiency
Phase 1
Completed
60 enrolled
Teva Neuroscience, Inc.
Teva Branded Pharmaceutical Products R&D, Inc. · collabTransPharma Medical · collab
RandomizedCrossoverDouble-blindTreatment
Summary
This study aims to examine the safety, tolerability and pharmacokinetics of transdermal delivery of human Growth Hormone (hGH or somatropin) using the ViaDerm device in adult patients with Growth Hormone Deficiency Syndrome.
Timeline
- Start
- 2007-04
- Primary completion
- 2007-10
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 0.2 mg | Subcutaneous |
| Subject | Somatropin | Protein / enzyme biologic | 0.4 mg | Subcutaneous |
| Subject | Somatropin | Protein / enzyme biologic | 0.5 mg | Subcutaneous |
| Subject | Somatropin | Protein / enzyme biologic | 1 mg | Subcutaneous |
| Subject | Somatropin | Protein / enzyme biologic | 2 mg | Subcutaneous |
| Subject | Somatropin | Protein / enzyme biologic | 5 mg | Subcutaneous |