Recovery and Survival of EryDex in Non-patient Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT02380924

Run by

Quince Therapeutics S.p.A.

People needed

10

Starts

2015-01-01

Expected to finish

2015-06-01

Last updated by the study team

2016-02-01

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• If female of childbearing potential*, the subject agrees not to donate ova and to use one of 4 methods of contraception from the time of signing the informed consent until 2 months after infusion
• If male, the subject agrees to not donate sperm and to use barrier contraception (e.g., condom with spermicidal cream or jelly) from the time of signing the informed consent until 2 months after infusion
• Physically and mentally healthy, as confirmed by medical history, physical examination, vital signs, clinical laboratory tests, and ECG
• Meets current physical examination guidelines for whole blood donation as set forth by the AABB (Reference Standard 5.4.1A, Standards for Blood Banks and Transfusion Services, 28th edition. Bethesda. TH Carson ed. 2012). Past travel restrictions do not apply for selection of subjects for this study
• Hemoglobin: ≥ 12.5g/dL
• Temperature: ≤ 37.5°C
• Ability to understand the objectives of the trial and comply with the study procedures

You may not qualify if…

• Females that are of childbearing potential, pregnant, or are breast-feeding Women of childbearing potential using two forms of birth control (e.g. barrier and hormonal) will be eligible
• Loss/removal of 500 mL or more of blood <4 weeks
• A disability that may prevent the subject from completing all study requirements
• Noncompliance with the study requirements
• Current participation in another clinical study
• Significant occupational exposure to ionizing radiation
• Current or previous neoplastic disease
• History of any impairment of the immunological system
• History of drug or alcohol abuse (<5 years)
• A current diagnosis of severe or unstable cardiovascular disease.
• Any history or current evidence of a cardiac illness as determined by the investigator.
• History or current diagnosis of a psychiatric illness, other than an anxiety disorder, or neurodegenerative disorder.
• History of hemoglobinopathy or G6PD deficiency.
• History of recurrent or chronic infections
• History of tuberculosis
• Have any other significant disease or condition that in the Investigator's opinion would put the subject at risk for participating in the trial, including acute gastric ulcer or diabetes.
• Vital signs persistently outside the following ranges:
• 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.
• Any clinically significant ECG abnormality
• Any clinically significant abnormality on standard laboratory examinations, as determined by the Investigator
• Positive serum pregnancy test
• Positive confirmed findings of an infectious disease based on results from the standard blood donor infectious disease screening panel
• Positive results of the drug or alcohol tests at baseline (Day 0 pre-dose) at the unit

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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