Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects

Exclusion Criteria

• •Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m2 at Screening.
• •Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of the need for such antibiotics during the Screening or treatment periods of the study.
• •Current or history of any clinically significant medical illness or disorder the Investigator considers should exclude the subject from the study.
• •Participation in any investigational intervention study within 30 days prior to study product administration in this study.
• •Known hypersensitivity to omeprazole.
• •Applicable only to certain study groups depending on emerging Stage 1 data: no current or anticipated use during the screening or treatment periods of the study of medications that have the potential for drug-drug interactions (DDI) with omeprazole.
• •Chronic kidney disease with eGFR \< 30 mL/min/1.73 m2 at Screening.
• •Evidence of current acute renal injury or ongoing clinically significant renal disease.
• •Oral or parenteral antibiotics within 4 weeks prior to Screening, or anticipation of the need for such antibiotics during the Screening or treatment periods of the study (topical antibiotics are permissible.)
• •Taking during the study any treatment for hyperoxaluria except for NOV-001, other than stable treatments for the management of kidney stones.
• •Taking Vitamin C ≥ 300 mg/day for \> 10 days within 7 days prior to Screening; unwilling or unable to discontinue and/or avoid Vitamin C supplementation for the duration of study product treatment.
• •Known active autoimmune disorder or other condition requiring high dose of systemic corticosteroids (i.e., \> 10 mg/day prednisone or equivalent) or other immunosuppressant therapy.
• •Current or history of any clinically significant medical illness or disorder other than enteric hyperoxaluria that the Investigator considers should exclude the patient from the study.
• •Participation in any investigational intervention study within 30 days prior to study product administration in this study.
• •Known hypersensitivity to omeprazole.