VRS-317 in Adult Subjects With Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01359488
• Date of registration: 13/05/2011
• Prospective Registration: No
• Primary sponsor: Versartis Inc.
• Public title: VRS-317 in Adult Subjects With Growth Hormone Deficiency
• Scientific title: 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
• Date of first enrolment: March 2011
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01359488
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Mark Kipnes, MD
• Affiliation: Diabetes and Glandular Disease Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 25 to 65 years

2. Negative serum pregnancy test for females of childbearing potential

3. Documented confirmation (medical history) of GHD during adulthood by one or more GH
stimulation test

4. If taking hormone replacement therapy other than rhGH, patient must be on a stable
course of treatment for 2 months prior to enrollment

5. Pituitary disorder associated with GHD has been clinically stable for at least 6
months

6. Currently receiving daily recombinant human growth hormone (rhGH) injections for
treatment of GHD for a minimum of 28 days

7. Willing and able to give informed consent

8. Within one year from enrollment, normal result from screening including: mammogram
(women), pap smear (women over 25), Men over 50 years old: digital rectal exam

Exclusion Criteria:

1. Subjects who have received systemic treatment for any bacterial, viral or fungal
infection within 30 days of the first study drug dosing (prophylactic acyclovir for
HSV is permitted)

2. Subjects with documented history of diabetes mellitus or inadequate glucose control
as defined by fasting plasma glucose level of greater than 126 mg/dL (7 mM) or HbA1c
of = 6.5% at screening

3. Subjects with untreated adrenal insufficiency.

4. Free thyroxine below normal reference range or TSH above normal reference range

5. Current use of oral or inhaled steroids except for physiological maintenance doses of
oral glucocorticoids in patients with multiple pituitary hormone deficiencies

6. Women using oral estrogens, including birth control pills, during study (transdermal
estrogen patches are allowed)

7. Current significant cardiovascular, cerebrovascular, pulmonary, neurological (not
related to GHD), renal or hepatobillary disease

8. Presence of retinopathy or papillaedema

9. Documented history of persistent (unresolved without medical intervention) or
recurring migraines, edema, arthralgia (not related to osteoarthritis), or nausea

10. History of drug or alcohol abuse.

11. Must not have documented prior history of HIV, HBV or HCV infection(testing not
required)

12. Prior history of cancer excluding adequately treated non-melanoma skin cancers or
adequately treated in situ carcinoma of the cervix

13. Women who are pregnant or breastfeeding

14. Unwilling to use two effective birth control methods until Day 60 of Treatment Phase

15. Pre-existing antibodies to human growth hormone at time of screening (screening
samples must be below pre-specified cut-off for positive anti-hGH antibody titer)

16. Treatment with an investigational drug within past 30 days prior to screening

17. Unable to comply with requirements of this study.



Age minimum: 25 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: VRS-317

Primary Outcome(s)

Safety and Tolerability of single dose of VRS-317 [Time Frame: 30 days]

Secondary Outcome(s)

Determine the pharmacokinetic (PK) profile of VRS-317 administered SC [Time Frame: 30 days]

Secondary ID(s)

VRS-317 1a

Source(s) of Monetary Support

Please refer to primary and secondary sponsors