NCT01228669

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B
• Healthy

Interventions

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

Timeline

• Start date: 2010-10-25
• Primary completion: 2012-09-10
• Completion: 2012-09-10
• First posted: 2010-10-26
• Last updated: 2019-05-15

Locations

16 sites across 11 countries: Austria, Denmark, Germany, Italy, Malaysia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom