NCT02490787

Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	Concizumab	Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)
DRUG	placebo	Administered subcutaneously (s.c., under the skin)

Timeline

• Start date: 2015-09-10
• Primary completion: 2016-10-14
• Completion: 2016-10-14
• First posted: 2015-07-07
• Last updated: 2017-07-21

Locations

34 sites across 15 countries: United States, Australia, Austria, Croatia, France, Germany, Israel, Malaysia, Netherlands, Poland, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom