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First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

NCT01514500 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-12-24

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.

Conditions

  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
  • Growth Hormone Deficiency in Children
  • Healthy

Interventions

DRUG

somapacitan

Administered s.c. (subcutaneously, under the skin)

DRUG

placebo (somapacitan)

Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-16
Primary Completion
2013-03-18
Completion
2013-03-18

Countries

  • Germany

Study Locations

More Related Trials

Entities

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 NCT01514500 on ClinicalTrials.gov