Safety and Pharmacokinetics of SANGUINATE™ in Sickle Cell Disease (SCD) Patients

Sickle Cell Disease (SCD) patients

Eligibility Criteria:

Sickle cell patients will be enrolled and will be selected based on:

Inclusion:

1. Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
2. Hb levels: > 6 gr/dl - <10 gr/dl;
3. Age: > 18 - 65 years;
4. Body Mass Index ≥20 and ≤30 kg/m2;
5. Documented 12-lead ECG with no clinically significant abnormalities, as determined by the Investigator;
6. Female subjects of reproductive potential must have a negative serum pregnancy (β-HCG) test at screening and a negative urine pregnancy test at Day 0 prior to dosing. Female subjects must also be non-lactating;
7. Adequate venous access and can receive intravenous infusions;
8. Frequency of ER hospitalizations < 6x/yr for SCD pain events documented "medical history".

Exclusion:

1. In medical opinion of investigator, the patient is not an appropriate candidate;
2. Patient is infected;
3. The patient is Febrile;
4. Patient has Acute chest syndrome or documented Sickle Cell Crisis;
5. Patient with hemoglobin above 10gr/dl or below 6 gm/dl
6. If female, pregnant or lactating;
7. History of clinically significant disease, as determined by the Investigator;
8. History of allergy or major allergic reaction considered to be clinically significant by the Investigator;
9. Physical examination or 12-lead ECG result(s) considered to be clinically significant by the Investigator;
10. Received or intending to receive a vaccination in the two weeks prior to dosing, or anytime during study participation;
11. Unable to comply with study attendance, protocol procedures or other study requirements;
12. Frequency of ER hospitalizations > 6x/yr for SCD pain events;
13. Patient has Renal or liver dysfunction;
14. Patient has Severe pulmonary hypertension (index > 3 meters per sec based on documented Echocardiograph);
15. Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results;
16. Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex, or other immunodeficiency;
17. Screening laboratory result indicating serologic positivity for hepatitis C antibodies or hepatitis B surface antigens, unless explained by a documented vaccination.