Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Phase 2 Completed 33 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults

Timeline

Start: 2008-07
Primary completion: 2009-03
Completion: 2009-03

Publications

Results Sondergaard E, Klose M, Hansen M, Hansen BS, Andersen M, Feldt-Rasmussen U, Laursen T, Rasmussen MH, Christiansen JS. Pegylated long-acting human growth hormone possesses a promising once-weekly treatment profile, and multiple dosing is well tolerated in adult patients with growth hormone deficiency. J Clin Endocrinol Metab. 2011 Mar;96(3):681-8. doi: 10.1210/jc.2010-1931. Epub 2010 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SOMATROPIN PEGOL	Protein / enzyme biologic	0.01 mg/kg	Subcutaneous
Subject	SOMATROPIN PEGOL	Protein / enzyme biologic	0.02 mg/kg	Subcutaneous
Subject	SOMATROPIN PEGOL	Protein / enzyme biologic	0.04 mg/kg	Subcutaneous
Subject	SOMATROPIN PEGOL	Protein / enzyme biologic	0.08 mg/kg	Subcutaneous

Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Summary

Timeline

Publications

Drugs

Indications