Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria

Eligibility Criteria

• 1. ≥ 18 to ≤ 50 years.
• 2. Willing to participate and sign the informed consent form.
• 3. Available for and agree to comply with all study requirements, including duration of stay at the clinical pharmacology unit, adherence to diet control, study drug administration, follow-up visits, and collection of stool, urine, and blood.
• 4. Normal clinical laboratory test results which are not considered to be clinically significant by the Investigator at Screening (including an estimated glomerular filtration rate \[eGFR\] \>60 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation).
• 5. Body mass index (BMI) 18 to 35 kg/m2.
• 6. Volunteers must have 24-hour urinary oxalate \<45 mg.
• 1. Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the Investigator.
• 2. Presence or history of any condition or procedure (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
• 3. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to admission on Day -7 or unwilling to forego other forms of investigational treatment during this study.
• 4. Major surgery or an inpatient hospital stay within 3 months prior to admission on Day -7.
• 5. A positive serologic test for infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
• 6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 × upper limit of normal (ULN).
• 7. Hemoglobin A1c (HbA1c) ≥6.5 percent.
• 8. Hyperthyroidism or hypothyroidism as defined by thyroid-stimulating hormone (TSH) levels outside the normal reference range.
• 9. History of QT prolongation or dysrhythmia or a family history of prolonged QT interval or sudden death.
• 10. Use of prescription drugs (except for hormonal contraceptives) including cisapride, pimozide, astemizole, terfenadine, ergotamine, or dihydroergotamine within 4 weeks prior to Screening and unable or unwilling to refrain from such use through the end of study visit.
• 11. Use of any herbal or over-the-counter medications, probiotic products, or vitamin supplements, including vitamin C, within 14 days prior to first administration of study drug through the end of the Confinement Period.
• 12. Planned procedures that may require antibiotics between Screening and the end of study visit.
• 13. Use of antibiotic treatment up to 4 weeks prior to or during Screening, or between Screening and admission (Day -7), or a history of recurrent infections requiring antibiotics.
• 14. A known hypersensitivity to MiraLax, clarithromycin, erythromycin, any of the macrolide antibiotics, metronidazole or other nitroimidazole derivatives.
• 15. A history of kidney stones.
• 16. Unwilling to comply with all study procedures and assessments, including the High Oxalate Low Calcium (HOLC) diet and the pretreatment regimen, which includes antibiotics.