NCT00715689

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Growth Hormone Disorder
• Adult Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	NNC126-0083	Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
DRUG	NNC126-0083	Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
DRUG	NNC126-0083	Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
DRUG	NNC126-0083	Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
DRUG	placebo	Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
DRUG	placebo	Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
DRUG	placebo	Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
DRUG	placebo	Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-07-15
• Last updated: 2017-02-08

Locations

3 sites across 1 country: Denmark