The Effects of GLA (5 mcg) on Human Volunteers

Exclusion Criteria

• •1. Positive for hepatitis B surface antigen, positive for hepatitis C antibodies, or active syphilis infection based on clinical evaluation;
• •2. Confirmed HIV-1 or HIV-2 infection;
• •3. Any clinically significant abnormality on medical history or physical examination including history of immunodeficiency or autoimmune disease;
• •4. Any use of systemic corticosteroids immunosuppressive anticancer medications;
• •5. Any clinically significant acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that in the opinion of the investigator would preclude participation;
• •6. Any laboratory value outside of reference range other than CRP, with the exception of any non-clinically significant Grade I elevations of liver function tests (AST, ALT, direct/total bilirubin), electrolytes (Na, K, Cl, CO2), CBC, urinalysis as determined by the Principal Investigator or his designee.
• •7. Within the 12 months prior to enrollment, the subject self reports excessive daily alcohol use, frequent binge drinking or chronic marijuana abuse (defined as greater than 2 times a week) or any other use of illicit drugs;
• •8. If female, pregnant, planning a pregnancy during the trial period, or lactating;
• •9. Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days prior to study drug;
• •10. Prior receipt of GLA in another research study;
• •11. Participation in another clinical study of an investigational product currently or within past 16 weeks, or expected participation during this study;
• •12. In the opinion of the investigator, unlikely to comply with protocol due to medical, social or psychiatric reasons;
• •13. Allergy to eggs
• •14. A glomerular filtration rate that is less than 60 mL/min/1.73 m2 as calculated by study team based on laboratory creatinine values.