A Single Dose Study of the Safety, Blood Levels and Biological Effects of Aes-103 Compared to Placebo in Subjects With Stable Sickle Cell Disease

Exclusion Criteria

• •Have evidence of clinically significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that may interfere with the objectives of the study or the safety of the subject, as judged by the investigator in agreement with the sponsor or medical monitor, or have been hospitalized in the past 6 months as a result of these conditions
• •Have been hospitalized in the 14 days before enrollment, for any reason
• •Be currently on regularly scheduled transfusions
• •Have received a transfusion within 2 weeks of administration of study drug
• •Have taken herbal preparations in the 2 weeks before dosing (Note: subjects are allowed concomitant usage of HU and other scheduled prescription drugs if the dosage is stable for the 2 months before screening and is at a dosage that does not exceed the product's labeling. These scheduled prescription medications will be continued during the study \[including during dosing\]. All other medications, including over-the-counter medications used according to the product labeling, administered on an as-needed basis will be permitted except for the 24 hour period before dosing and the day of dosing. Medications for pain management will be allowed as needed \[including during dosing.\])
• •Have taken any other investigational drug within 30 days or 5 half-lives before the screening visit, whichever is longer
• •Consumed more than 14 alcoholic drinks per week or more than 3 drinks per day at any point in the past month
• •Have received disulfiram or 4-methylpyrazole within 30 days before dosing
• •Have taken any cough-cold product containing dextrorphan or dextromethorphan within 4 days before dosing
• •Have positive result for urine drug test (cocaine, marijuana, opiates, amphetamines, methamphetamines, benzodiazepines, ethanol) at screening visit. However, use of opiates, amphetamines, or benzodiazepines is allowed if prescribed by a physician.
• •Have engaged in strenuous exercise within 72 hours prior to dosing
• •Be considered not suitable for participation in this study for any reason, as judged by the investigator
• •Have pre-existing allergic or other adverse reactions to orange juice