CompletedPhase 1

Recovery and Survival of EryDex in Non-patient Volunteers

United States10 participantsStarted 2015-01

Plain-language 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).

Who can participate

Age range18 Years – 55 Years

SexALL

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Exclusion criteria

✕. Systolic blood pressure \<90 or \>140 mmHg
✕. Diastolic blood pressure \<50 or \>90 mmHg
✕. Pulse \<50 or \>90 bpm. Patients with pulse rates \<50 that are otherwise healthy will be eligible for the trial if approved by the Sponsor.

What they're measuring

24-hour post transfusion recovery of infused autologous RBCs

Timeframe: 24 hours

Long-term survival of infused autologous RBCs assessed with T50 (Time to disappearance of 50% of the labelled red blood cells from the circulation)

Timeframe: up to 49 days

Trial details

NCT IDNCT02380924

SponsorQuince Therapeutics S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

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