Clinical trial: Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Intravenous Doses of RSV604 in Healthy Subjects. (NCT00416442)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy male and female subjects, 18-50 years of age, in good health as determined by
             past medical history, physical examination, vital signs, electrocardiogram, and
             laboratory tests at screening.

          -  Vital signs within the following parameters:

        oral body temperature between 35.0-37.5 °C systolic blood pressure, 85-140 mm Hg diastolic
        blood pressure, 50-90 mm Hg pulse rate, 40 - 100 beats per minute (bpm)

          -  Female subjects must have been surgically sterilized at least 6 months prior to
             screening, with supportive clinical documentation OR Postmenopausal women must have no
             regular menstrual bleeding for at least 1 year prior to inclusion.

          -  Body mass index (BMI) must be within the range of 18 to 30 kg/m2. Subjects must weigh
             at least 50 kg to participate in this study.

        Exclusion Criteria:

          -  Smokers (use of tobacco products in the previous 3 months). Smokers will be defined as
             any subject who reports tobacco use or has a urine cotinine greater than 300 ng/ml

          -  Participation in any clinical investigation involving medical intervention within 4
             weeks before study start

          -  Donation or loss of 400 ml or more of blood within 8 weeks prior to before study start

          -  Significant illness within 2 weeks before study start

          -  A past personal or close family medical history of clinically significant ECG
             abnormalities or of a prolonged QT-interval syndrome.

          -  History of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension).

          -  History of acute or chronic bronchospastic disease (including asthma and chronic
             obstructive pulmonary disease, treated or not treated),

          -  History of clinically significant drug allergy or history of atopic allergy (asthma,
             urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs
             similar to the study drug particularly benzodiazepines.

          -  Any surgical or medical condition which might significantly alter the absorption,
             distribution, metabolism or excretion of drugs or which may jeopardize the subject in
             case of participation in the study, including bowel, gastrointestinal, renal,
             pancreatic, hepatic, hematological, immunological, or neurological disorders.

        Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years

Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? Contradiction