Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers

Single-centre, Randomised, Placebo-controlled, Double-blind, Dose Escalation Trial Investigating Pharmacokinetics, Pharmacodynamics and Tolerability of Three Different Single Intravenous Doses of Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®) in Healthy Caucasian and Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01563471

Enrollment

Registered

2012-03-27

Start date

2001-10-31

Completion date

2002-07-31

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors, Healthy

Brief summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.

Interventions

DRUGactivated recombinant human factor VII

Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Caucasian or Japanese * Healthy as defined by medical history, physical and biological examinations

Exclusion criteria

* History of allergy or hypersensitivity reaction to any medication * History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication * Alcohol or substance abuse disorder * Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health

Design outcomes

Primary

Measure	Time frame
Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours	—

Secondary

Measure	Time frame
Mean residence time (MRT)	—
Maximum plasma concentration (Cmax)	—
Time to reach maximum plasma concentration (tmax)	—
Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)	—
Adverse events	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026