A Double-Blind Randomized Placebo-Controlled Study to Assess the Safety Tolerability and Pharmacodynamics of SYNB8802 in Healthy Volunteers and in Patients with Enteric Hyperoxaluria | NYU Langone Health

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A Double-Blind Randomized Placebo-Controlled Study to Assess the Safety Tolerability and Pharmacodynamics of SYNB8802 in Healthy Volunteers and in Patients with Enteric Hyperoxaluria

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Enteric Hyperoxaluria
Age: Between 18 years - 64 years
Gender: Male or Female

Other Inclusion Criteria:
1. Participants must provide signed written informed consent form
2. Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, follow-up visits, and compliance with all study procedures
3. Have enteric hyperoxaluria secondary to Roux-en-Y bariatric surgery
4. Male subjects who are sexually abstinent or surgically sterilized, or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception combined with a recommendation for use of an acceptable method of contraception for their non-pregnant female partner(s)
5. Female subjects who have childbearing potential must have a negative pregnancy test and must agree to use acceptable method(s) of contraception, combined with a recommendation for use of an acceptable method of contraception for their male partner(s)
6. Screening laboratory evaluations and electrocardiogram (ECG) must be within normal limits

You may not be eligible for this study if the following are true:

1. Acute or chronic medical, surgical, psychiatric, or social condition or laboratory abnormality that may increase subject risk associated with study participation, compromise adherence to study procedures and requirements, or may confound interpretation of study safety or PD results and, in the judgment of the investigator, would make the subject inappropriate for enrollment
2. Acute renal failure
3. Unable or unwilling to discontinue vitamin C supplementation for the study duration
4. Diagnosis of primary hyperoxaluria or any other cause of hyperoxaluria
5. Oxalobacter formigenes carrier
6. Pregnant (self or partner), or lactating
7. Currently taking or plans to take any type of systemic (e.g., oral or intravenous) antibiotic within 30 days prior to Day 1 through the final safety assessment
8. Major surgery or inpatient hospital stay within the past 3 months
9. Planned surgery, hospitalizations, dental work, or interventional studies
10. Taking or planning to take probiotic supplements
11. Intolerance of or allergic reaction to EcN, esomeprazole and all other PPIs, or any of the ingredients
12. Dependence on alcohol or drugs of abuse
13. History of or current immunodeficiency disorder including autoimmune disorders and HIV antibody positivity, Hepatitis B surface antigen positivity or Hepatitis C antibody positivity
14. Enrolled in a investigational study
15. History of bacteremia within 30 days
16. History of inflammatory bowel disease