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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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)
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.
AE
Time frame: 36 days
Laboratory values
Time frame: 36 days
Vital signs
Time frame: 36 days
ECG
Time frame: 36 days
Patch application site reaction: Skin irritation- erythema, edema
Time frame: 36 days
Patch application site reaction: Pain - Visual Analogue Scale
Time frame: 36 days
Proportion of subjects (%) who discontinue the study
Time frame: 36 days
Proportion of subjects (%) who discontinue the study due to AEs
Time frame: 36 days
Pharmacokinetics: Somatropin exposure including Cmax, Tmax, AUC, AUC, Ke, and T1/2.
Time frame: 36 days
Pharmacodynamics: Human IGF-1 levels and AUC.
Time frame: 36 days
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