A Randomised, Double Blind, Placebo-controlled, Single Dose, Dose-escalating Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin® SimpleXx® in Healthy Male Subjects

NCT01034202 Phase 1 COMPLETED

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers

Details

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	COMPLETED
Enrolment	56
Start date	2007-08
Completion	2008-01

Conditions

• Growth Hormone Disorder
• Healthy

Interventions

• NNC126-0083
• Norditropin® SimpleXx®
• placebo
• NNC126-0083
• Norditropin® SimpleXx®

Primary outcomes

• Number of adverse events — after administration of a single dose of NNC126-0083

Countries

Denmark