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

NCT00715689 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-02-08

No results posted yet for this study

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

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

Sponsors & Collaborators

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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00715689 on ClinicalTrials.gov