A Double-Blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome
Study SYNB8802-CP-002 is designed to assess safety, tolerability, and oxalate lowering, in subjects with a history of gastric bypass surgery or short-bowel syndrome. In addition, this study will explore other PD effects relative to baseline as well as predictors of efficacy and tolerability.
• Age ≥ 18 to ≤ 74 years.
• Able and willing to voluntarily complete the informed consent process.
• Available for, and agree to, all study procedures, including fixed diet, feces, urine, and blood
• collection, follow-up visits, and compliance with all study procedures.
• History of gastric bypass surgery (at least 12 months prior to Day 1) or short-bowel
• If taking probiotic supplements (enriched foods excluded), has been on a stable, well tolerated dose for at least 2 weeks prior to Day 1.
• Women of childbearing potential must have a negative pregnancy test (human chorionic
• gonadotropin) at screening and at baseline prior to the start of IMP.
• Screening laboratory evaluations (e.g., chemistry panel, complete blood count with
• differential, prothrombin time, urinalysis) and electrocardiogram (ECG) must be within
• normal limits or judged not to be clinically significant by the investigator. Subjects with
• known diabetes should be well controlled and have an A1c of ≤ 8% within 3 months prior to Day 1.
• Agree to abstain from tobacco/nicotine use for the duration of the inpatient stay.
• Subjects who are HIV positive, on therapy with normal CD4 counts and undetectable viral loads, can be included.