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Growth Hormone Secretagogue Receptor Agonist

VRS-317 Safety Arm 2 for Human Growth Hormone Deficiency

Phase 1
Waitlist Available
Led By Mark Kipnes, MD
Research Sponsored by Versartis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Summary

The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients. * Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes from baseline in insulin-like growth factor-1 (IGF-I) and binding protein (IGFBP-3), and bone turnover (bone alkaline phosphatase) * Descriptive pharmacokinetic (PK) and pharmacodynamic (PD) parameters (IGF-I and IGFBP-3) will be determined by standard model independent methods based on the plasma concentration-time data of each subject. These parameters include: Cmax, Tmax, AUCavg, AUC0-inf, and t1/2. * The purpose is to determine the appropriate dose of VRS-317 to maintain a normal range (for appropriate age/gender) for IGF-I levels in adult patients for up to one month after administration of a single dose

Eligible Conditions
  • Human Growth Hormone Deficiency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability of single dose of VRS-317
Secondary study objectives
Determine the pharmacokinetic (PK) profile of VRS-317 administered SC

Trial Design

5Treatment groups
Experimental Treatment
Group I: VRS-317 Safety Arm 5Experimental Treatment1 Intervention
VRS-317 Two injections SC of dose level 5 (based on 90 kg patient) Placebo Two SC injections Dose Volume matched to active treatment volume
Group II: VRS-317 Safety Arm 4Experimental Treatment1 Intervention
VRS-317 Two injections SC of dose level 4 (based on 90 kg patient) Placebo Two SC injection Dose matched to treatment volume
Group III: VRS-317 Safety Arm 3Experimental Treatment1 Intervention
VRS-317 Single injection SC of dose level 3 (based on 90 kg patient) Placebo Single SC injection Dose Volume matched to active treatment volume
Group IV: VRS-317 Safety Arm 2Experimental Treatment1 Intervention
VRS-317 Single injection SC of dose level 2 (based on 90 kg patient) Placebo Single SC injection Dose Volume matched to active treatment volume
Group V: VRS-317 Safety Arm 1Experimental Treatment1 Intervention
VRS-317 Single injection SC of dose level 1 (based on 90 kg patient) Placebo Single SC injection Dose Volume matched to active treatment volume
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatotropin
FDA approved

Find a Location

Who is running the clinical trial?

Versartis Inc.Lead Sponsor
7 Previous Clinical Trials
721 Total Patients Enrolled
1 Trials studying Human Growth Hormone Deficiency
21 Patients Enrolled for Human Growth Hormone Deficiency
Mark Kipnes, MDPrincipal InvestigatorDiabetes and Glandular Disease Clinic
6 Previous Clinical Trials
708 Total Patients Enrolled
~3 spots leftby Sep 2025
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