Recovery and Survival of EryDex in Non-patient Volunteers

EryDex System (EDS) is a combination product used to administer dexamethasone sodium
phosphate (DSP) by ex vivo encapsulation in autologous erythrocytes which are re-infused.
DSP is dephosphorylated in RBCs to release dexamethasone.

The 12 subjects who meet all of the inclusion/exclusion criteria will be assigned to one of
the 2 groups, consisting of 6 subjects each, as follows:

- Group 1 (active drug arm): 15-20 mg DSP loaded in RBC using the EDS.

- Group 2 (sham arm): sham treated autologous RBC using the EDS

One 50±5mL aliquot of blood collected from each subject will be treated using the EDS
process (either active drug or sham) and the resultant processed RBCs will be radiolabeled
with Chromium-51 (51Cr) for the in vivo kinetic study. A second 10±5mL simultaneously
collected sample will be labeled with Technetium-99m (99mTc) to estimate the subject's blood
volume. These labeled aliquots will be mixed, and simultaneously infused through a
peripheral vein via butterfly or similar catheter (total dose 20-40 μCi). Blood samples will
be collected from the subject's contralateral arm immediately pre-infusion and at 5, 7.5,
10, 12.5, 15, 20, and 30 minutes (± 3 min), and on Day 1, 24 hours (±2 h) after completion
of infusion. Vital signs will be assessed after the 30-min sample on Day 0 and again on Day
1 before the 24-h sample is collected. Additional blood samples will be collected at 48 (±4
h) and 72 (±4 h) hours and 7 (±1 d) days post-infusion, and then weekly through 49 days
post-infusion, with a window of ±2 days for each visit.

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.