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(BYI-0736) The Effects of GLA on Human Volunteers

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A Randomized, Blinded, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Immunogenicity of GLA in Healthy Volunteers

Principal Investigator:
Bryan Yipp MD

Christine Trumpfheller Ph.D.
Ralph M. Steinman M.D.
Lauren Sinnenberg
Sarah Schlesinger M.D.
Sarah Pollak RN
Saurabh Mehandru M.D.
Arlene Hurley ANP-BC
Marina Caskey M.D.
Gaelle Breton MSc
Niroshana Anandasabapathy M.D., Ph.D.

Contact Information:
Lauren Sinnenberg
The Rockefeller University
1230 York Avenue
New York, NY 10065
Telephone: 212.327.7946
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The immune system protects the body from invading substances. In this study we want to learn more about a drug called Glucopyranosyl Lipid A (GLA) and how it works to boost the immune system. GLA is a drug used in combination with vaccines to make them work better, and is not used to treat a condition on its own. Although GLA has been studied previously in humans with a flu vaccine, we would like to examine how your body will respond to GLA by itself. What we learn about GLA in this study will help us design future vaccine trials. Some of the study investigators will be involved in both studies, and some of those investigators and The Rockefeller University will gain a financial benefit if the vaccine studied advances to a commercial product.

Detailed Description of Protocol:
About 32 people will take part in the research study at The Rockefeller University Hospital.

Participation includes:
- Receiving the investigational drug 1 time
- 6 visits to our Outpatient Research Center
- Blood work

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- Age 18 to 60
- Healthy



Children permitted to participate:

Potential Benefits.....
There will be no benefit to you other than receiving physical exams and getting information about your general health. Instead, others may benefit in the future from what we learn from this study.

Compensation is provided.