EryDex Pharmacokinetics in Healthy Volunteers

Exclusion Criteria

• •General
• •1. Females that are of childbearing potential, pregnant, or are breast-feeding. Women of childbearing potential using two forms of birth control (e.g. barrier and hormonal) will be eligible.
• •2. Loss/removal of 500 mL or more of blood within the past 4 weeks.
• •3. A disability that may prevent the subject from completing all study requirements.
• •4. Noncompliance with the study requirements. Medical History
• •5. Current or previous neoplastic disease.
• •6. History of any impairment of the immunological system.
• •7. History of drug or alcohol abuse (within past 5 years).
• •8. A current diagnosis of severe or unstable cardiovascular disease;
• •9. Any history or current evidence of a cardiac illness as determined by the investigator;
• •10. History or current diagnosis of a psychiatric illness (DSM-IV-TR Axis I diagnosis) or neurodegenerative disorder.
• •11. Smoker; currently or at any time in the last 6 months.
• •12. Hemoglobinopathy or G6PD deficiency.
• •13. History of recurrent or chronic infections, including Staphylococcus or methicillin-resistant Staphylococcus aureus (MRSA).
• •14. History of positive tuberculosis skin test (PPD test). Current Medical Status
• •15. Have any other significant disease or condition that in the Investigator's opinion would put the subject at risk for participating in the trial.
• •16. Vital signs outside the following ranges:
• •1. Systolic blood pressure \<90 or \>140 mmHg
• •2. Diastolic blood pressure \<50 or \>90 mmHg
• •3. Pulse \<50 or \>90 bpm. Patients with pulse rates \<50 that are otherwise healthy will be eligible for the trial if approved by the Sponsor.
• •17. Any clinically significant ECG abnormality, including a disorder of rate, rhythm, or conduction, or other morphological changes.
• •18. Any clinically significant abnormality on standard laboratory examinations (hematology, biochemistry, urinalysis), as determined by the Investigator, in consultation with the Sponsor.
• •19. History of hepatitis B and/or C, and/or positive serology results, which indicate the presence of hepatitis B and/or C (Hepatitis B surface antigen and/or antibody to Hepatitis C).
• •20. Positive results from the HIV serology.
• •21. Positive results of the drug and alcohol tests at screening and/or check-in at the unit. Alcohol intake should be limited to 2 drinks per day during the 2 weeks prior to dosing; alcohol consumption will be prohibited from the time o
• •22. Clinically significant abnormal serum cortisol levels (below normal range or \>1.5x ULN) at screening.
• •Prior/Concomitant Medication
• •23. Any previous steroid consumption within 4 weeks before Baseline.
• •24. Chronic condition or prior allergic reaction representing a contraindication to the use of steroid drugs.
• •25. Have participated in any other trial with an investigational drug and received a dose within 30 days or 10 half-lives (whichever is greater) from the start of the Screening Period.
• •26. Requirement for any prescription or over-the-counter (OTC) medication, other than hormonal birth control or occasional use of acetaminophen, that cannot be discontinued during screening, at least one week before Baseline, and throughout the 42-day study period.
• •f admittance on Day -1 through to the final safety evaluations on Day 42.
• •27. A drug or treatment known to cause major organ system toxicity during the past year.
• •28. Caffeine-containing products in excess of the equivalent of 2 cups of coffee per day during the 2 weeks prior to dosing and through to the final safety evaluations on Day 42.