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Recovery and Survival of EryDex in Non-patient Volunteers

NCT02380924 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-02-01

No results posted yet for this study

Summary

This is a randomized, single-blind, single-center, concurrently controlled, exploratory, Phase I study to determine the in vivo kinetics (24-hour post-infusion recovery and T50 survival) of EryDex System (EDS) -processed autologous red blood cells (RBC) in non-patient volunteers. A total of 12 non-patient volunteer subjects will be enrolled and assigned to one of the 2 groups (6 subjects in active arm group, 6 subjects in sham arm group).

Conditions

  • Healthy

Interventions

DRUG

DSP loaded RBC using EryDex System

Intravenous infusion of 10 mg DSP encapsulated in autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC.

DRUG

Sham treated RBC using the EryDex System

Intravenous infusion of sham treated autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC.

Sponsors & Collaborators

  • Quince Therapeutics S.p.A.

    lead INDUSTRY

Principal Investigators

  • Larry J Dumont, PhD, MBA · Dartmouth Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT02380924 on ClinicalTrials.gov