The Effects of GLA on Human Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Healthy Volunteers
Interventions
DRUG

GLA-AF

GLA-AF contains GLA, a new synthetic lipid A molecule that combines 6 acyl chains with a single phosphorylation site. GLA-AF contains GLA in an aqueous solution. One 2 mcg injection will be given per patient in the upper arm, each randomized to either subcutaneous or intramuscular routes.

DRUG

GLA-SE

GLA-SE contains GLA, a new synthetic lipid A molecule that combines 6 acyl chains with a single phosphorylation site. GLA-SE contains GLA in a squalene oil emulsion. One 2 mcg injection will be given per patient in the upper arm, each randomized to either subcutaneous or intramuscular routes.

OTHER

Squalene

Squalene is a natural organic compound obtained from shark liver oil. In this study, it is used to solubilize GLA in the GLA-SE formulation. Patients randomized to receive the squalene will be given one 2mcg injection of the squalene oil in the upper arm, each patient randomized further to either subcutaneous or intramuscular routes.

Trial Locations (1)

10065

The Rockefeller University, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

IDRI Corporation

UNKNOWN

collaborator

Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

lead

Rockefeller University

OTHER