NCT01925859

EryDex Pharmacokinetics in Healthy Volunteers

Pharmacokinetics Study to Measure Plasma Concentrations of Dexamethasone Following EryDex (Dexamethasone Sodium Phosphate Encapsulated in Autologous Erythrocytes) Infusion in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Quince Therapeutics S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare the pharmacokinetic properties of two different doses of EryDex (dexamethasone sodium phosphate encapsulated in erythrocytes) given as a single infusion in healthy volunteers, based on plasma concentrations of dexamethasone.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)	erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System)-corresponding to either 50 mg OR 125mg of experimental study drug

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-08-20
• Last updated: 2015-06-01

Locations

1 site across 1 country: United States