A Study to Assess the Safety and Pharmacokinetics of HBI-002, an Oral Carbon Monoxide Therapeutic, in Healthy Volunteers

Inclusion Criteria

• Signed informed consent.
• Healthy male or female 18-55 years of age inclusive.
• Negative HBsAg, aHCV, aHIV, and SARS-CoV-2 test.
• Non-smoker or vaper (no use of tobacco or marijuana products within 3 months of screening).
• Body weight between 60 kg and 110 kg (inclusive) and with BMI less than 30 kg/m2.
• Subjects must be healthy as defined by:
• absence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, as determined by the Investigator.
• liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤2 times the upper limit of the normal range
• total bilirubin ≤1.5 times the upper limit of the normal range
• renal function: creatinine clearance within normal range as assessed by Cockcroft and Gault calculation
• carboxyhemoglobin level by venous blood gas ≤ 3.5% (any time prior to the first dose)
• venous lactate level <2.0 mmol/L at baseline.
• the absence of current clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests (hematology and clinical chemistries), as determined by the Investigator.
• Negative pregnancy tests for females.
• Subjects must be willing to use a highly effective method of contraception for the duration of the study and for 30 days thereafter.
• Male subjects, without a vasectomy, must use a condom and be instructed that their female partner should use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation if the female partner could become pregnant
• Female subjects of childbearing potential (not surgically sterilized and less than one year post-menopausal) should use a form of contraception such as an IUD, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation, and be instructed that their male partners should use a condom, if not vasectomized.

Exclusion Criteria

Subjects who meet any of the following criteria will be ineligible for participation in the study:

• Subjects with concurrent illness/disease as defined by:
• clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, as determined by the Investigator.
• current clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests (hematology, clinical chemistries and urinalysis), as determined by the Investigator.
• clinically significant illness and/or surgery within 4 weeks prior to dosing.
• Anemia of any cause.
• Homozygous or heterozygous hemoglobinopathy.
• Blood transfusion within six weeks prior to the first administration of study drug.
• Carboxyhemoglobin ≥ 3.5% (any time prior to the first dose)
• Oxygen saturation by transcutaneous measurement consistently ≤ 95% (any time prior to the first dose)
• Exposure to any live vaccine within 28 days prior to study drug administration.
• History of febrile or infective illness within 14 days prior to dosing.
• Positive pregnancy test or breast feeding for females.
• Weight loss or gain of more than 5 kg within 3 months prior to dosing.
• History of alcohol abuse or dependence or regular use of alcohol within six months prior to dosing (defined as more than 14 units of alcohol per week; 1 Unit= 150 mL wine, 360 mL beer or 45 mL of 40% alcohol)
• Positive result on alcohol screen
• History of pulmonary infiltrate or pneumonia within 6 months prior to dosing or pulmonary/bronchial infection within 2 weeks prior to dosing.
• History of cancer, with the exception of adequately treated bas