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.
Single group
HBI-002
DrugOral liquid carbon monoxide drug product.
Frequency and severity of Treatment Emergent Adverse Events, including adverse events of special interest
Maximum hemoglobin concentration (Cmax) as measured by carboxyhemoglobin (COHb) saturation
Elimination half-life (t1/2) as measured by COHb saturation
Change from baseline in complete blood count (CBC) test parameters, including hemoglobin, hematocrit, red blood cell (RBC) count, white blood cell (WBC) count, and neutrophil count
Change from baseline in inflammation and oxidation, as assessed by levels of protein and/or mRNA indicators, particularly those associated with heme oxygenase-1 (HO-1)
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Hillhurst Biopharmaceuticals, Inc.
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
