Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Phase 1 Completed 40 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 a NNC126-0083 in healthy male Japanese subjects.

Timeline

Start: 2008-07
Primary completion: 2009-04
Completion: 2009-04

Publications

Results Rasmussen MH, Jensen L, Anderson TW, Klitgaard T, Madsen J. Multiple doses of pegylated long-acting growth hormone are well tolerated in healthy male volunteers and possess a potential once-weekly treatment profile. Clin Endocrinol (Oxf). 2010 Dec;73(6):769-76. doi: 10.1111/j.1365-2265.2010.03863.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
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
Subject	SOMATROPIN PEGOL	Protein / enzyme biologic	0.16 mg/kg	Subcutaneous

Indications

No indication recorded.