NCT02380924 is a Phase 1 clinical trial of DSP loaded RBC using EryDex System in Healthy, sponsored by Quince Therapeutics S.p.A..

Who is sponsoring NCT02380924?

NCT02380924 is sponsored by Quince Therapeutics S.p.A..

What drugs are being tested in NCT02380924?

Interventions in NCT02380924: DSP loaded RBC using EryDex System, Sham treated RBC using the EryDex System.

Is NCT02380924 still recruiting?

NCT02380924 is currently completed. Last updated 29 January 2016.

Last reviewed 2016-01-29 · How we verify

NCT02380924

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Determination of the in Vivo Recovery and Survival of EryDex (Dexamethasone Sodium Phosphate Encapsulated in Autologous Erythrocytes) in Non-patient Volunteers

Completed Phase 1 Last updated 29 January 2016

What this trial tests

Phase 1 trial testing DSP loaded RBC using EryDex System in Healthy in 10 participants. Completed in 1 June 2015.

Timeline

1 January 2015

Primary endpoint
1 June 2015

1 June 2015

Quick facts

Lead sponsor	Quince Therapeutics S.p.A.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	10
Start date	1 January 2015
Primary completion	1 June 2015
Estimated completion	1 June 2015
Sites	1 location across United States

Drugs / interventions tested

DSP loaded RBC using EryDex System — full drug profile →
Sham treated RBC using the EryDex System — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Quince Therapeutics S.p.A. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

24-hour post transfusion recovery of infused autologous RBCs
Time frame: 24 hours
The 24-hour recovery of autologous RBCs loaded with DSP or sham using the EDS will be greater than 75% with 95% confidence. For RBC kinetics and recovery will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.
Long-term survival of infused autologous RBCs assessed with T50 (Time to disappearance of 50% of the labelled red blood cells from the circulation)
Time frame: up to 49 days
For RBC T50 will be reported as mean, 2-sided 95% CI on the mean, standard deviation, minimum and maximum.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Red blood cells: Supercarriers for drugs, biologicals, and nanoparticles and inspiration for advanced delivery systems.
Villa CH, Anselmo AC, Mitragotri S, Muzykantov V. · · 2016 · cited 259× · PMID 26941164 · DOI 10.1016/j.addr.2016.02.007
Ongoing Developments and Clinical Progress in Drug-Loaded Red Blood Cell Technologies.
Rossi L, Pierigè F, Aliano MP, Magnani M. · · 2020 · cited 34× · PMID 32198632 · DOI 10.1007/s40259-020-00415-0
A Machine-Learning-Based Bibliometric Analysis of Cell Membrane-Coated Nanoparticles in Biomedical Applications over the Past Eleven Years.
Zhang Y, Jin S, Li D, Chen G, et al · · 2023 · cited 1× · PMID 37020629 · DOI 10.1002/gch2.202200206

Verify or expand the search:

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Other Quince Therapeutics S.p.A. trials

Trials by the same sponsor.

NCT06664853 — Open-Label Extension of EryDex Study IEDAT-04-2022 · Phase 3 · terminated
NCT06193200 — Evaluate the Neurological Effects of EryDex on Subjects With A-T · Phase 3 · completed
NCT03563053 — Extension Treatment Using EryDex System in Patients With AT Who Participated in the ATTeST-IEDAT-02-2015 Study · Phase 3 · terminated
NCT02770807 — Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients · Phase 3 · completed
NCT01171807 — Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02380924 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Quince Therapeutics S.p.A.
Last refreshed: 29 January 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02380924.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing