Recovery and Survival of EryDex in Non-patient Volunteers

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Erydel
• Treatments: Dexamethasone 21-phosphate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Systolic blood pressure <90 or >140 mmHg

2. Diastolic blood pressure <50 or >90 mmHg

3. 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

• Any previous oral or parenteral steroid use <4 weeks before baseline. Treatment with inhaled or intranasal steroids for asthma or allergies, as well as use of topical steroids will be permitted

• Chronic condition or prior allergic reaction representing a contraindication to the use of dexamethasone or other steroid drugs

• Have participated in any other trial with an investigational drug and received a dose <30 days or 10 half-lives (whichever is greater) from the start of the screening period.

• Requirement for any concomitant medication prohibited by the protocol. Subjects with a history of treatment with oral or depot antipsychotic medication will be excluded

• A drug or treatment known to cause major organ system toxicity during the past year.