At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-centre, Randomised, Placebo-controlled, Double-blind, Single-dose, Dose-escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Intravenous Doses of an Activated Recombinant FVII Analogue (NN1731) in Healthy Japanese Male Subjects
In Brief
A Phase 1 clinical trial evaluating vatreptacog alfa (activated) and placebo for Congenital Bleeding Disorder and Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined
Study Details
Timeline
Interventions
One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg
One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg
One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg
One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg
Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg