Reversible Albumin-Binding GH Possesses a Potential Once-Weekly Treatment Profile in Adult Growth Hormone Deficiency.

ABSTRACT:

Context

NNC0195-0092 is a reversible, albumin-binding GH derivative, developed for once-weekly administration.

Objectives

The objective of the study was to evaluate safety, local tolerability, pharmacodynamics, and pharmacokinetics of multiple, once-weekly doses of NNC0195-0092, compared with daily GH.

Design and setting

This was a phase 1, randomized, open-label, active-controlled, multiple-dose, dose-escalation trial.

Patients

Thirty-four GH-treated adult subjects (male, n = 25) with GH deficiency participated in the study.

Interventions and main outcome measures

Subjects were sequentially assigned into four cohorts of eight subjects, randomized within each cohort (3:1) to once-weekly NNC0195-0092 (n = 6) for 4 weeks (0.02, 0.04, 0.08, and 0.12 mg/kg)

SUBMITTER: Rasmussen MH 

PROVIDER: S-EPMC4803179 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature