Status:
COMPLETED
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief 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 (physiolo...
Eligibility Criteria
Inclusion
- Body weight between 50 and 100 kg, both inclusive
- Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive
- For haemophilia subjects only: Diagnosed with severe haemophilia A or B
Exclusion
- Known or suspected hypersensitivity to trial product(s) or related products
- Surgery planned to occur during the trial
- Any major and/or orthopaedic surgery within 30 days prior to trial product administration
Key Trial Info
Start Date :
October 25 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01228669
Start Date
October 25 2010
End Date
September 10 2012
Last Update
May 15 2019
Active Locations (16)
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1
Novo Nordisk Investigational Site
Vienna, Austria, 1090
2
Novo Nordisk Investigational Site
Copenhagen, Denmark, 2100
3
Novo Nordisk Investigational Site
Berlin, Germany, 10249
4
Novo Nordisk Investigational Site
Frankfurt/M., Germany, 60590