Long-acting Human Growth Hormone (VRS-317) in Pre-pubertal Children with Growth Hormone Deficiency: Phase 1b/2a Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy after Subcutaneous Administration for 6 Months

-
Investigator: Stephen M. Rosenthal, MD
Sponsor: Versartis, Inc

Location(s): United States

Description

This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6 months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317.