Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 11, 2017

Primary Completion Date

January 3, 2018

Study Completion Date

June 20, 2018

Conditions
Arthritis, Rheumatoid
Interventions
BIOLOGICAL

Cantharidin

5 microliter (µL) of 0.2 percent Cantharidin solution (diluted in acetone) will be applied to all subjects on forearm by topical route.

BIOLOGICAL

Lipopolysaccharide

0.5 to 4 ng/kg body weight of LPS formulated as suspension in normal saline will be administered to randomized subjects via intravenous (IV) route in dose-escalation manner.

BIOLOGICAL

Granulocyte-Macrophage Colony-Stimulating Factor

5 to 15 µg/kg of GM-CSF will be administered to randomized subjects via subcutaneous (SC) route in the abdominal region in dose-escalation manner.

DRUG

Saline Solution

0.9 percent sodium chloride will be administered via IV route to all subjects at a rate of 250 mL/hour for 4 hours prior to dosing with LPS and 8 hours after dosing with LPS.

Trial Locations (1)

CB2 2GG

GSK Investigational Site, Cambridge

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03306589 - Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects | Biotech Hunter | Biotech Hunter