Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor

Community sample

Inclusion Criteria:

• Be male, aged between 18 and 35 years inclusive, and with a body weight of at least 60 kg and a body mass index (BMI) between 18.5 and 25 kg/m2 inclusive.
• Be without clinical significant abnormalities according to the investigator's judgment, based on a detailed medical history, a complete physical examination (including vital signs), a standard 12-lead electrocardiogram, urinalysis, and routine clinical laboratory tests.
• Have endogenous C1-inhibitor, α2-antiplasmin, fibrinogen, and plasminogen levels within the laboratory's reference range.
• Have a negative serology for HIV, HBsAg, and HCV.
• Have a negative test for alcohol and drugs of abuse at screening and on study day -1.
• Be capable of understanding and willing to comply with the conditions and restrictions of the protocol.
• Have read, understood and provided written informed consent.

Exclusion Criteria:

• Has a known or suspected inherited, congenital, or acquired disease or condition that affects the haemostatic or coagulation pathways or that is associated with an increased bleeding tendency.
• Has a reasonable chance of developing a clinically significant bleeding event or a bleeding event that may go undetected for a considerable amount of time during the study, for example:
• Has undergone major (internal) surgery or trauma within the last three months of the anticipated dosing day;
• Has an intestinal or cerebral vascular malformation;
• Has participated in high impact contact sports, such as kick-boxing, within two weeks of the anticipated dosing day.
• Has received any systemically absorbed drug or substance (including prescription, over-the-counter, or alternative remedies) that is not permitted by this protocol prior to dosing without undergoing a wash-out period of at least seven times the elimination half-life of the product. For aspirin or other products inhibiting thrombocyte-aggregation the wash-out period must not be less than 28 days.
• Has smoked tobacco in any form within three months of dosing, or has ever smoked more than five cigarettes per day (or equivalent) on average.
• Has received blood or plasma derivatives in the year preceding the administration day.
• Has lost blood or plasma outside the limits of the local blood donation service (i.c. Sanquin) three months prior to dosing.
• Has a known hypersensitivity to any of the investigational material or related compounds.
• Has a history of severe hypersensitivity or of an allergy with severe reactions.
• Has a history of substance abuse, including caffeine, tobacco, and alcohol.
• Has a condition or demonstrates an attitude that in the opinion of the investigator might jeopardise the subject's health or well-being, or the scientific integrity of the study results.
• Is mentally or legally incapacitated to provide informed consent.