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EryDex Pharmacokinetics in Healthy Volunteers

NCT01925859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-06-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Quince Therapeutics S.p.A.

    lead INDUSTRY

Principal Investigators

  • Mohamed Al-Ibrahim, MD · SNBL Pharmacology Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01925859 on ClinicalTrials.gov