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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

activated recombinant human factor VII, long acting

Intervention Type DRUG

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.

B

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

C

Group Type EXPERIMENTAL

activated recombinant human factor VII, long acting

Intervention Type DRUG

Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).

Interventions

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activated 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.

Intervention Type DRUG

placebo

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.

Intervention Type DRUG

activated recombinant human factor VII, long acting

Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes