cerebral infarction stroke
Conditions
Interventions
Screening
This includes an evaluation of the inclusion and exclusion criteria to check
for eligibility. This evaluation will be performed within 2 to 28 days before
study drug administration.
In-cli
Sponsors
Acticor Biotech SAS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant, non-breastfeeding females, aged *18 and 65 years. Female subjects must be of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or as post-menopausal females defined as 12 months amenorrhea and follicle stimulating hormone (FSH) levels >40 IU/L. 2. Body mass index (BMI) *18 kg/m2 and 30 kg/m2 at screening. 3. A resting pulse *40 beats per minute (bpm) and *100 bpm at screening and on Day -1. 4. A resting systolic blood pressure of *150 mmHg and a resting diastolic blood pressure of *95 mmHg at screening and on Day -1. 5. Baseline laboratory test values within reference ranges based on the blood and urine samples taken at screening and on Day -1. Out of normal ranges values may be accepted by the Investigator, if not clinically significant. Values for hemostasis and coagulation blood test, for bleeding time and platelet aggregation should be normal.
Exclusion criteria
Exclusion criteria: 1. The subject has a history of hemorrhagic disease or venous or arterial thrombotic disease. 2. The subject has a history or presence of any disorder with an increased risk of bleeding (e.g. ulcus pepticus, hemorrhoids). 3. The subject has used drugs modifying hemostasis or platelet function within the last month prior to administration of the study drug (i.e. aspirin, antiplatelet drugs, anti-vitamin K drugs and anticoagulant drugs). 4. The subject has used anti-histamines within the last month prior to administration of the study drug. 5. The subject has taken prescription or non-prescription medication, herbal remedies, vitamins or minerals within 2 weeks prior to administration of the study drug (or within 5 half-lives prior to administration of the study drug for any medication ingested, whichever is longer).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics Pharmacokinetic parameters will be derived by non-compartmental analysis of the platelet free plasma concentration-time profiles. Details will be specified in the pharmacokinetics (PK) analytical plan. Pharmacodynamics * Bleeding time * Collagen-induced platelet aggregation | — |
Primary
| Measure | Time frame |
|---|---|
| Safety * Adverse Events (AEs) * Clinical laboratory results * Electrocardiogram (ECG) * Vital signs * Coagulation parameters (PT, PTT, INR) * Platelet count * GPVI expression * Immunogenicity / anti-drug antibodies (ADA) | — |
Countries
Netherlands
Outcome results
None listed