Brief Title
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
Official Title
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-0000-2021 Administered Intravenously and Subcutaneously to Healthy Male Subjects and Haemophilia Subjects
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 (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
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of adverse Events (AEs), including Serious Adverse Events (SAEs)
Secondary Outcome
Area under the concentration-time curve
Condition
Congenital Bleeding Disorder
Intervention
NNC 0172-0000-2021
Study Arms / Comparison Groups
A
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
52
Start Date
October 25, 2010
Completion Date
September 10, 2012
Primary Completion Date
September 10, 2012
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
Male
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01228669
Organization ID
NN7415-3813
Secondary IDs
2010-020465-24
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
May 2019