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

Healthy Clinical Trial

— Explorer 1  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B
• Healthy
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

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

External Links

•   Clinical Trials at Novo Nordisk