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Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B

NCT01228669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-05-15

No results posted yet for this study

Summary

This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B
  • Healthy

Interventions

DRUG

NNC 0172-0000-2021

Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose

DRUG

NNC 0172-0000-2021

Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.

DRUG

placebo

Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.

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
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-25
Primary Completion
2012-09-10
Completion
2012-09-10

Countries

  • Austria
  • Denmark
  • Germany
  • Italy
  • Malaysia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

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 NCT01228669 on ClinicalTrials.gov