VRS-317 11VR1.1 Version 3

• Research type

  Research Study

• Full title

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

• IRAS ID

  77029

• Eudract number

  2010-024088-42

• ISRCTN Number

  not known

• Research summary

  The study is designed to evaluate safety and tolerability of a single injection of VRS-317 in patients with growth hormone deficiency. This is a single ascending dose (SAD) study and each patient will be assigned to a treatment group that will receive one dose of study drug. There will be up to five treatment groups and up to 5 doses studied. Subjects will be dosed on Day 1 and monitored for 48 hours in the Health Care Facility (HCF). Additional safety assessments will be made at end of treatment (Day 30) and at follow up (Days 44 and 60). Assessments of insulin-like growth factor-1 (IGF-Ibinding protein (IGFBP-3), and bone turnover (bone alkaline phosphatase) will be made to determine the best dose of VRS-317 needed to maintain a normal range for IGF-I levels in adult patients for one month after receiving a single dose. VRS-317 is being studied to determine if it can provide levels of human growth hormone necessary for normal growth comparable to daily growth hormone injection therapy. This will substantially reduce the number of injections of growth hormone required by patients on this therapy. The study will be conducted in up to 4 phases: 1) Screening phase, 2) Daily rhGH therapy phase (for patients not currently on daily rhGH therapy), 3) Withdrawal phase (all enrolled patients will stop daily rhGH therapy), and 4) Treatment Phase with VRS-317, the investigational drug. Patients will participate for a total of 74-120 days.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/0836

• Date of REC Opinion

  11 Jul 2011

• REC opinion

  Further Information Favourable Opinion