Clinical Trials

Inclusion Criteria - Stage 1 (Healthy Volunteers) Stage 1:

• Male or female subject ≥ 18 and ≤ 55 years of age.
• Body mass index (BMI) < 38 kg/m^2.
• Healthy as defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including vital signs, and clinical laboratory tests.
• Porphyran utilization by gut microbiota determined by fecal quantitative polymerase chain reaction (qPCR) assay for the porphyran polysaccharide utilization locus (PUL).
  • Note: Treatment Group PU is reserved only for up to a maximum of 8 subjects who have porphyran-utilizing gut microbiota. All other treatment and control groups are designated only for subjects without porphyran-utilizing gut microbiota.
• If woman of child-bearing potential (i.e., not pre-menarchal, surgically permanently sterile [hysterectomy, bilateral salpingectomy and bilateral oophorectomy], or ≥ 12 months post-menopausal without an alternative medical cause), must not be pregnant as confirmed by a negative pregnancy test (serum beta-human chorionic gonadotropin [hCG]) prior to study enrollment, and must also agree to use an appropriate highlyeffective contraceptive method (i.e., sexual abstinence; oral, intravaginal, or transdermal combined estrogen and progesterone hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progesterone-only hormonal contraception associated with inhibition of ovulation; intrauterine device [IUD]; intrauterine hormone-releasing system [IUS]; bilateral tubal occlusion; or only vasectomized sexual partner[s]) for the duration of treatment with study product and for 12 weeks after cessation of study product treatment.
• 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 24-hour urine collections.
• Able to understand the requirements of this study and has provided written informed consent for participation in the study.

Exclusion Criteria - Stage 1:

• Breast-feeding or anticipated to be breast-feeding during the treatment period.
• Current or history of drug-dependency or drug abuse.
• Positive results from urine drug screen during Screening and at baseline.
• History of regular alcohol consumption > 14 drinks/week for female subject or > 21 drinks/week for male subject, where 1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor, within 3 months prior to Screening.
• Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m^2 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. (Topical antibiotics are permissible.)
• Known ongoing clinically significant renal disease, such as acute or chronic renal failure, renal tubular acidosis, chronic urinary tract infection, renal colic, pure uric acid and/or cysteine stones.
• Current clinical diagnosis of chronic diarrhea or constipation.
• Positive pregnancy test during Screening.
• Unable to tolerate venipuncture.
• Known bleeding disorder or history of prolonged bleeding or easy bruising.
• Current or history of any clinically significant medical illness or disorder the Investigator considers should exclude the subject from the study, including (but not limited to) neurological, cardiovascular, hepatic, renal, gastrointestinal, respiratory, metabolic, or skeletal system diseases.
• Any acute or chronic medical condition that, in the opinion of the Investigator, increases the risk to the subject or the likelihood that the subject will be unable to complete the full duration of the study.
• Unable or unwilling to comply with all requirements of the protocol.
• Participation in any investigational intervention study within 30 days prior to study product administration in this study.

Inclusion Criteria - Stage 2 (EH Patients) Stage 2:

• Male or female ≥ 18 and ≤ 65 years of age.
• Hyperoxaluria secondary to Roux-en-Y gastric bypass surgery.
• 24-Hour urinary oxalate (UOx) ≥ 60 mg based on the mean of two adequate collections during Screening at least 3 days apart, and neither < 50 mg oxalate.
• If woman of child-bearing potential (i.e., not pre-menarchal, surgically permanently sterile [hysterectomy, bilateral salpingectomy and bilateral oophorectomy], or ≥ 12 months post-menopausal without an alternative medical cause), must not be pregnant as confirmed by a negative pregnancy test (serum beta-human chorionic gonadotropin [hCG]) prior to study enrollment, and must also agree to use an appropriate highly-effective contraceptive method (i.e., sexual abstinence; oral, intravaginal, or transdermal combined estrogen and progesterone hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progesterone-only hormonal contraception associated with inhibition of ovulation; intrauterine device [IUD]; intrauterine hormone-releasing system [IUS]; bilateral tubal occlusion; or only vasectomized sexual partner[s]) for the duration of treatment with study product and for 12 weeks after cessation of study product treatment.
• Must, in the opinion of the Investigator, be in good health based upon medical history and physical examination including vital signs.
• 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.
• Able to understand the requirements of this study and has provided written informed consent for participation in the study.

Exclusion Criteria - Stage 2:

• Known primary hyperoxaluria Type 1, 2 or 3, according to standard diagnostic criteria.
• Determined to have porphyran-utilizing gut microbiota by fecal qPCR assay for the porphyran PUL.
• Breast-feeding or anticipated to be breast-feeding during the treatment period.
• Greater than 30% variability in the ratio of creatinine (mg)/body weight (kg) between the two 24-hour urine samples collected during Screening.
• Chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at Screening.
• Evidence of current acute renal injury.
• Active glomerular disease requiring treatment with immunosuppressive agent(s).
• Known ongoing clinically significant renal disease, such as acute renal failure, distal (Type 1) and/or proximal (Type 2) renal tubular acidosis, chronic urinary tract infection, renal colic, pure uric acid and/or cysteine stones.
• 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.)
• Current clinical diagnosis of chronic diarrhea or constipation.
• Currently taking or anticipated to be taking during the study any treatment of hyperoxaluria except for NOV-001, except that may be taking drugs for the management of kidney stones (e.g., pyridoxine [Vitamin B6], thiazide diuretics, citrate and calcium supplements, alkali therapy, allopurinol [e.g., Zyloprim® and Aloprim®]) as long as there have been no changes in these medications for at least 2 months prior to Screening, and no anticipated change over the duration of this study.
• 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 intensification of other immunosuppressant therapy.
• Positive pregnancy test during Screening.
• Unable to tolerate venipuncture.
• Known bleeding disorder or history of prolonged bleeding or easy bruising.
• Current or history of drug-dependency or drug abuse.
• Current or history of any clinically significant medical illness or disorder the Investigator considers should exclude the patient from the study, including (but not limited to) neurological, cardiovascular, hepatic, renal, gastrointestinal, respiratory, metabolic, or skeletal system diseases.
• Any acute or chronic medical condition that, in the opinion of the Investigator, increases the risk to the patient or the likelihood that the patient will be unable to complete the full duration of the study.
• Unable or unwilling to comply with all requirements of the protocol.
• Participation in any investigational intervention study within 30 days prior to study product administration in this study.

Eligibility last updated 8/20/21. Questions regarding updates should be directed to the study team contact.