A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

A Single-centre, Randomised, Placebo-controlled, Double-blind Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Local Tolerability of Ascending Subcutaneous Doses of Long Acting-rFVIIa in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00951873

Enrollment

Registered

2009-08-04

Start date

2009-07-31

Completion date

2010-04-30

Last updated

2016-05-13

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, Haemophilia B, Healthy

Brief summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).

Interventions

DRUGactivated recombinant human factor VII, long acting

Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.

DRUGplacebo

Single injection of long acting activated recombinant human factor VII placebo subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Caucasian origin * Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive * Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)

Exclusion criteria

* Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®) * Previous participation in this trial, defined as randomised to receive trial product * Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator * Known history of atherosclerosis or thromboembolic events * Overt bleeding, including from gastrointestinal tract * Hepatitis B or C infection * HIV infection * Positive test for drugs of abuse

Design outcomes

Primary

Measure	Time frame
Number of adverse events	assessed throughout the trial period from visit 1 to visit 5

Secondary

Measure	Time frame
Area under activity concentration-time curve from time zero to infinity	assessed up to 168 hours after trial product administration

Countries

United Kingdom

Outcome results

None listed

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