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 Overview
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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).

Official Title
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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

Conditions
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Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy

Intervention / Treatment
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* Drug: activated recombinant human factor VII, long acting
* Drug: placebo
* Drug: activated recombinant human factor VII, long acting


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: activated recombinant human factor VII, long acting<br>* 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.<br>|
| Placebo Comparator: B<br> | Drug: placebo<br>* 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.<br>|
| Experimental: C<br> | Drug: activated recombinant human factor VII, long acting<br>* Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | assessed throughout the trial period from visit 1 to visit 5 | 

Secondary Outcome Measures

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