NCT00722540

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

Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Growth Hormone Disorder
• Healthy

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 3 repeated; NNC126-0083 placebo for 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 3 repeated; NNC126-0083 placebo for 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 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-07-25
• Last updated: 2017-02-08

Locations

1 site across 1 country: Germany