The Effects of GLA (5 mcg) on Human Volunteers

Inclusion criteria

• Healthy adult males and females, as assessed by a medical history, physical exam,and laboratory tests;
• Age of at least 18 years of age on the day of screening and no greater than 50 years at time of administration;
• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study (screening plus 4 weeks);
• Willing to undergo HIV testing and counseling and receive HIV test results;
• If a female of child bearing potential, must be willing to use two effective methods of contraception (combined oral contraceptive pill; injectable contraceptive; diaphragm; Intra Uterine Device (IUD); condoms; anatomical sterility in self or partner) until 6 weeks after study drug administration. If a sexually active male, must be willing to use two effective methods of contraception (such as condoms, anatomical sterility) from screening until 6 weeks after study drug administration (same as above) and will be advised not to get his partner(s) pregnant during this time.

Exclusion criteria

• Positive for hepatitis B surface antigen, positive for hepatitis C antibodies, or active syphilis infection based on clinical evaluation;
• Confirmed HIV-1 or HIV-2 infection;
• Any clinically significant abnormality on medical history or physical examination including history of immunodeficiency or autoimmune disease;
• Any use of systemic corticosteroids immunosuppressive anticancer medications;
• 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;
• 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.
• 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;
• If female, pregnant, planning a pregnancy during the trial period, or lactating;
• Receipt of a live attenuated vaccine within 30 days or other vaccine within 14 days prior to study drug;
• Prior receipt of GLA in another research study;
• Participation in another clinical study of an investigational product currently or within past 16 weeks, or expected participation during this study;
• In the opinion of the investigator, unlikely to comply with protocol due to medical, social or psychiatric reasons;
• Allergy to eggs
• A glomerular filtration rate that is less than 60 mL/min/1.73 m2 as calculated by study team based on laboratory creatinine values.