Inclusion Criteria- Patients with acute ischemic stroke (scoring 3-20 on the National Institutes of Health Stroke Scale [NIHSS]) with level of consciousness score: 0 or 1 (conscious patients) are eligible to be treated within 9 hours of onset of stroke symptoms.
- For female patients: post-menopausal or surgically sterile (post-menopausal: age ≥55 years and last menses ≥3 years ago).
Exclusion Criteria- Participation in any investigational study in the previous 30 days.
- Patients unable to understand trial related information.
- History or evidence of severe heart diseases further specified in the protocol.
- History or evidence of additional diseases or results of baseline visit as specified in the protocol.
- Use of concomitant and prior medications as defined in the protocol.