This is a multi-center, open label Phase 2a clinical trial in subjects with sickle cell disease to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of HBI-002, an orally administered liquid containing carbon monoxide (CO), with doses daily for 14 days.
Signed informed consent.
Male or female 14-55 years of age inclusive.
Negative Hepatitis B surface antigen (HBsAg), anti-Hepatitis C (aHCV), anti-Human Immunodeficiency Virus (aHIV), and SARS-CoV-2 test. Subjects that test SARS-CoV-2 positive at screen or baseline can be re-screened at least four weeks after the positive test so long as they are asymptomatic and test negative.
Non-smoker or vaper (no use of tobacco or marijuana products within 3 months of screening).
Hemoglobinopathy other than SCD or S/beta 0 thalassemia.
Clinical, ECG or laboratory evidence of cardiac dysfunction as determined by the PI.
Acute chest syndrome or VOC within 21 days or signs or symptoms of an impending vaso-occlusive crisis as determined by both the subject and PI immediately prior to first dosing with HBI-002/placebo.
Current smoker.
Hillhurst Biopharmaceuticals, Inc.
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator