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

Novo Nordisk A/S38 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A Haemophilia B Healthy

Interventions

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.

placeboDRUG

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of adverse events

Time frame: assessed throughout the trial period from visit 1 to visit 5

Secondary Outcomes

Area under activity concentration-time curve from time zero to infinity

Time frame: assessed up to 168 hours after trial product administration