Ensayos clínicos

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 omeprazole.

Stage 2 Key Inclusion Criteria:

- Ages 18 to 65.

- Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery or to biliopancreatic
diversion with duodenal switch (BPD-DS) surgery.

- 24-Hour urinary oxalate (UOx) ≥ 60 mg.

- If woman of child-bearing potential, must not be pregnant and must also agree to use
an appropriate highly effective contraceptive method.

- Must, in the opinion of the Investigator, be in otherwise good health.

- Willing and able to comply with all study requirements, including dietary
restrictions, daily study product administration, pregnancy testing and contraception
(if applicable), stool collections, and blood and 24-hour urine collections.

Stage 2 Key Exclusion Criteria:

- 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.