NCT01864876

The Effects of GLA (5 mcg) on Human Volunteers

A Randomized, Single-Blinded Phase 1 Study to Evaluate the Safety and Immunogenicity of a Single Administration of 5 mcg GLA in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Access to Advanced Health Institute (AAHI) · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 subcutaneously. The second focus will be to detail the global immune response by measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be to investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells. The results of this trial will generate supportive human data to use GLA as an adjuvant in a dendritic cell-targeted vaccine strategy.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	GLA-AF	Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF).
BIOLOGICAL	GLA-SE	Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE).
BIOLOGICAL	EM060G (SE)	The same stable oil-in-water emulsion (SE), but without GLA.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-05-30
• Last updated: 2014-02-26

Locations

1 site across 1 country: United States