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hGH-ViaDerm System · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| hGH-ViaDerm™ System (hGH or somatropin) | DRUG | transdermal patch; Group 1: 0.2 mg/day SC hGH during Period I, and 0.5 mg per transdermal patch during Period III (expected equivalent dose to SC 0.2 mg/day) Group 2: 0.4 mg/day SC hGH during Period I, and 2.0 mg per transdermal patch during Period III (expected equivalent dose to SC 0.4 mg/day) Group 3: 1.0 mg/day SC hGH during Period I, and 5.0 mg per transdermal patch during Period III (expected equivalent dose to 1.0 mg/day) |
| hGH-ViaDerm™ System | DEVICE | The hGH-ViaDerm™ System is a transdermal delivery system for somatropin (hGH, rDNA origin). The ViaDerm System™ consists of a medical device component and a printed dry hGH patch component. The device component is comprised of two primary elements: a reusable, computer mouse-like electronic controller and a disposable sterile array, which is inserted onto the base of the controller, delivers RF-current to ablate cells and creates microscopic throughways, termed RF-MicroChannels™, across the stratum corneum into the upper epidermis. The drug component consists of a unique circular transdermal dry hGH patch formulated specifically for use with the ViaDerm™ device. hGH is delivered by passive diffusion through the RF-MicroChannels™ into the systemic circulation system. |
Inclusion Criteria: Ages Eligible for Study: 20 Years - 60 Years, Genders Eligible for Study: Both 1. Clinical diagnosis of Adult Growth Hormone Deficiency (AGHD) meeting one of the following criteria: * Three or more additional pituitary hormone deficiencies, based on well documented medical ...
hGH-ViaDerm System is an investigational drug being developed for the treatment of Growth Hormone Deficiency in adults. It is a small molecule therapy in the endocrine therapeutic area. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
hGH-ViaDerm System is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development for Growth Hormone Deficiency.
hGH-ViaDerm System is in Phase 1 clinical development. It is an investigational drug for Growth Hormone Deficiency and has not been approved for marketing. One Phase 1 clinical trial has been completed for this drug.
hGH-ViaDerm System has one completed clinical trial, identified as NCT00455260. This was a Phase 1, multi-dose study to assess tolerability, safety and pharmacology of the drug in adults with Growth Hormone Deficiency. The trial enrolled 60 participants.
hGH-ViaDerm System is a distinct investigational drug being developed for Growth Hormone Deficiency. It is a small molecule therapy in Phase 1 clinical development by Teva Pharmaceutical Industries Limited. No alternative names for this drug have been established.