Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Versartis Inc.
In Phase 1b, separate cohorts of patients will be tested in a single ascending dose format. Safety review committee meetings will take place prior to escalating to each increasing dose level. Enrolled patients will be monitored for 60 days for safety with PK/PD and safety labs collected.
Two dose levels will be selected after completion of Phase 1b to be tested during Phase 2a (6 months of continuous VRS-317 treatment). Safety and PK assessments will be made during the Phase 2a stage. Patient heights will be measured by stadiometer.
Age
3–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Chronological Age ≥ 3.0 years and ≤ 11.0
Diagnosis of GHD as documented by GH stimulation test
Below average height SDS at screening
Appropriate weight for Stature
Decreased IGF-I SDS at screening
Delayed bone age
Normal thyroid function test results at screening visit
