Versartis International Trial in Adults With Long-Acting Growth Hormone

A Phase 2, dose finding safety study to evaluate an individualized monthly VRS-317 dosing
regimen in adults with GHD. This is an open-label, international, multicenter study with
VRS-317 treatment for five months. This treatment period will include monthly dose
titrations until a subject's mean IGF-I SDS value is within a target range for two
consecutive months. Subjects will be stratified into three cohorts based on sensitivity to
rhGH.

Inclusion Criteria:

- Female subjects of childbearing potential must have negative pregnancy test and use
appropriate contraceptive methods

- Subjects must have documented GHD during adulthood.

- Subjects taking other hormone replacement therapy must have been on a stable course
of treatment for at least 3 months.

- Subjects with underlying disorders responsible for the subject's GHD must have been
clinically stable for at least 6 months.

- Subjects receiving daily rhGH injections must washout for 14 days.

- Subjects must provide signed informed consent.

- Subjects must have a BMI (kg/m2) between 19.0 and 35.0.

Exclusion Criteria:

- Subjects with diabetes mellitus or inadequate glucose control

- Subjects with untreated adrenal insufficiency.

- Subjects with free thyroxine outside the normal reference range.

- Subjects currently taking oral glucocorticoids, except for physiological maintenance
doses of oral glucocorticoids in subjects with multiple pituitary hormone
deficiencies.

- Subjects with current significant cardiovascular disease, heart insufficiency of NYHA
class > 2.

- Subjects with current significant cerebrovascular, pulmonary, neurological, renal,
inflammatory, or hepatobiliary disease.

- Subjects with current papilledema.

- Subjects with a history of persistent or recurring migraines.

- Subjects with current edema (≥ CTCAE Grade 2).

- Subjects with current drug or alcohol abuse.

- Subjects with a documented history of HIV, current HBV or HCV infection

- Subjects with a prior history of malignancy excluding adequately treated non-melanoma
skin cancers or in situ carcinoma of the cervix.

- Women who are pregnant or breastfeeding.

- Subjects with a significant abnormality in Screening laboratory results