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

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

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

Sponsors & Collaborators

• Novo Nordisk A/S

  lead INDUSTRY

Principal Investigators

• Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2009-04-30

Completion

2009-04-30

Countries

• Germany

Study Locations