A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)

Novo Nordisk A/S1 site in 1 country24 target enrollmentSeptember 10, 2015

ConditionsCongenital Bleeding Disorder Haemophilia A

InterventionsConcizumab placebo

DrugsConcizumab placebo

Overview

Phase: Phase 1
Intervention: Concizumab
Conditions: Congenital Bleeding Disorder
Sponsor: Novo Nordisk A/S
Enrollment: 24
Locations: 1
Primary Endpoint: Number of adverse events (AEs)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 10, 2015

End Date

October 14, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
•Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
•Age between 18 and 64 years both inclusive, at the time of signing informed consent
•Body weight between 50 and 100 kg, both inclusive

Exclusion Criteria

•Known or suspected hypersensitivity to trial product or related products
•Platelet count below 50x10\^9/L at screening
•Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
•Subjects at increased risk of cardiovascular disease as judged by the investigator

Arms & Interventions

Concizumab

Intervention: Concizumab

Concizumab

Intervention: placebo

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Number of adverse events (AEs)

Time Frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Secondary Outcomes

Trough level of concizumab(Prior to the last s.c. dose administration (day 42))
Frequency of binding non-neutralizing anti-concizumab antibodies(From first trial drug administration (day 1) to 11 weeks after the first trial product administration)