Status:
COMPLETED
The Effects of GLA (5 mcg) on Human Volunteers
Lead Sponsor:
Access to Advanced Health Institute (AAHI)
Collaborating Sponsors:
Rockefeller University
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF administered subcutane...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01864876
Start Date
September 1 2012
End Date
December 1 2013
Last Update
February 26 2014
Active Locations (1)
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1
Rockefeller University
New York, New York, United States, 10065