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

Stage 1 Key Inclusion Criteria: * Ages 18 to 55 * Body mass index (BMI) \< 38 kg/m2. * Healthy as defined by no clinically relevant abnormalities being identified by a detailed medical history, physical examination, and clinical laboratory tests. * If woman of child-bearing potential, must not be pregnant, and must also agree to use an appropriate highly-effective contraceptive. * Willing and able to comply with all study requirements, including duration of stay at inpatient unit, dietary restrictions, daily study product administration, pregnancy testing and contraception (if applicable), stool collections, and blood and urine collections. Stage 1 Key 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 omepraz…