NCT01514500

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.

Conditions

• Growth Hormone Disorder
• Adult Growth Hormone Deficiency
• Growth Hormone Deficiency in Children
• Healthy

Interventions

Type	Name	Description
DRUG	somapacitan	Administered s.c. (subcutaneously, under the skin)
DRUG	placebo (somapacitan)	Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)

Timeline

• Start date: 2012-01-16
• Primary completion: 2013-03-18
• Completion: 2013-03-18
• First posted: 2012-01-23
• Last updated: 2020-12-24

Locations

1 site across 1 country: Germany