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Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

NCT02490787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-07-21

No results posted yet for this study

Summary

This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A

Interventions

DRUG

Concizumab

Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)

DRUG

placebo

Administered subcutaneously (s.c., 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
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-10
Primary Completion
2016-10-14
Completion
2016-10-14

Countries

  • United States
  • Australia
  • Austria
  • Croatia
  • France
  • Germany
  • Israel
  • Malaysia
  • Netherlands
  • Poland
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • 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 NCT02490787 on ClinicalTrials.gov