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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01228669
Other study ID # NN7415-3813
Secondary ID 2010-020465-24U1
Status Completed
Phase Phase 1
First received
Last updated
Start date October 25, 2010
Est. completion date September 10, 2012

Study information

Verified date May 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date September 10, 2012
Est. primary completion date September 10, 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

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
NNC 0172-0000-2021
Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.
placebo
Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.

Locations

Country Name City State
Austria Novo Nordisk Investigational Site Wien
Denmark Novo Nordisk Investigational Site København
Germany Novo Nordisk Investigational Site Berlin
Germany Novo Nordisk Investigational Site Frankfurt/M.
Italy Novo Nordisk Investigational Site Milano
Malaysia Novo Nordisk Investigational Site Kuala Lumpur
South Africa Novo Nordisk Investigational Site Polokwane Limpopo
Spain Novo Nordisk Investigational Site Madrid
Sweden Novo Nordisk Investigational Site Malmö
Switzerland Novo Nordisk Investigational Site Zürich
Thailand Novo Nordisk Investigational Site Bangkok
United Kingdom Novo Nordisk Investigational Site Harrow
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Manchester

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

References & Publications (1)

Chowdary P, Lethagen S, Friedrich U, Brand B, Hay C, Abdul Karim F, Klamroth R, Knoebl P, Laffan M, Mahlangu J, Miesbach W, Dalsgaard Nielsen J, Martín-Salces M, Angchaisuksiri P. Safety and pharmacokinetics of anti-TFPI antibody (concizumab) in healthy v — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse Events (AEs), including Serious Adverse Events (SAEs) from trial product administration until 43 days after trial product administration
Secondary Area under the concentration-time curve from 43 days after trial product administration until 53 days after trial product administration
Secondary Adverse Events (AEs), including Serious Adverse Events (SAEs) from 43 days after trial product administration until 53 days after trial product administration
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