VRS-317 Single injection SC of dose level 1 (based on 90 kg patient)
Placebo Single SC injection Dose Volume matched to active treatment volume

VRS-317 Single injection SC of dose level 2 (based on 90 kg patient)
Placebo Single SC injection Dose Volume matched to active treatment volume

VRS-317 Single injection SC of dose level 3 (based on 90 kg patient)
Placebo Single SC injection Dose Volume matched to active treatment volume

VRS-317 Two injections SC of dose level 4 (based on 90 kg patient)
Placebo Two SC injection Dose matched to treatment volume

VRS-317 Two injections SC of dose level 5 (based on 90 kg patient)
Placebo Two SC injections Dose Volume matched to active treatment volume

Growth Hormone Deficiency

VRS-317

Diabetes and Glandular Disease Clinic

VRS-317 in Adult Subjects With Growth Hormone Deficiency

A Blinded Placebo Controlled Single Ascending Dose Phase 1 for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Subcutaneous Administration of VRS-317 in Adults With Growth Hormone Deficiency

This study will evaluate the differences between VRS-317 dose levels and placebo for adverse events. Summaries will be provided for each dose cohort and for the combined dose cohorts including the number of patients with adverse events. All subjects who receive at least one dose of VRS-317 or placebo will be included in the safety analysis. Summaries of all adverse events (AEs)and serious adverse events (SAEs)will be classified according to severity and relationship to study drug.

Parameters
Pharmacokinetic (PK)parameters are determined from WinNonLin analysis using a one compartment model. [Timeframe = 30 days] Cmax Tmax AUCavg AUC0-inf t1/2
Parmacodynamic (PD)parameters are determined from WinNonLin analysis using a one compartment model. [Timeframe = 30 days] Cmax Tmax AUCavg AUC0-inf t1/2
IGF-I and IGFBP-3 values compared against baseline parameters and parameters obtained from daily rhGH treatment. [Timeframe = 90 days]

adrenal insufficiency/phosphatase

VRS-317 in Adult Subjects With Growth Hormone Deficiency

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