A long-acting human growth hormone with delayed clearance (VRS-317): results of a double-blind, placebo-controlled, single ascending dose study in growth hormone-deficient adults.

ABSTRACT:

Background

Administration of daily recombinant human GH (rhGH) poses a considerable challenge to patient compliance. Reduced dosing frequency may improve treatment adherence and potentially overall treatment outcomes.

Objectives

This study assessed the safety and tolerability and the potential for achieving IGF-I levels within the target range in adults with GH deficiency after a single dose of the long-acting rhGH analog, VRS-317.

Design

This was a randomized, double-blind, placebo-controlled, single ascending dose study.

Patients

Fifty adults with growth hormone deficiency (mean age, 45 years) were studied in 5 treatment groups of 10 subjects each (8 active drug and 2 placebo).

Setting

The study was conducted in 17 adult endocrinology centers in North

SUBMITTER: Yuen KC 

PROVIDER: S-EPMC3667252 | biostudies-literature | 2013 Jun

REPOSITORIES: biostudies-literature