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
Brief description of study
SYNB8802 (the drug being tested) is a live biotherapeutic (biologicals) being developed as a potential treatment for enteric hyperoxaluria (EH). EH is a condition in which a person’s body does not properly absorb fat in the intestine, which leads to higher than normal levels of oxalate, a natural substance found in the human body and in many foods. High levels of oxalate can cause kidney stones and other, sometimes serious kidney conditions. People who have EH must follow a special diet to avoid foods that contain oxalate and fat, and they must take supplements (for example, calcium salts) to help the body get rid of extra oxalate. This study will include 2 parts. The information contained in this informed consent will focus on the second part of this study. Participants with EH will receive SYNB8802 at or below the highest dose that was tolerated in Part 1 or placebo (no active ingredient). Only Part 2 will be conducted at NYU to investigate whether it is safe and tolerable in EH participants.
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