The study of of SYNB8802v1 for patients with gastric bypass surgery or short-bowel syndrome

Synlogic is recruiting patients for the clinical trial of 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.

This is a double-blind (sponsor-open), randomized (3:2), placebo-controlled, inpatient study evaluating the safety and tolerability of SYNB8802v1 in subjects with a history of gastric bypass surgery or short-bowel syndrome. An interim analysis of results by an unblinded statistician will be performed after 10 subjects. The study includes the following periods: - Screening period (27 days) - Diet run in (3 days) - Dosing Period (12 days) - Safety follow-up (28 days).

The maximum duration of the inpatient stay will be 17 days (Day -4 to Day 13). Subjects will report to the clinical research unit (CRU) on Day -4 and will complete a 3-day diet run-in period (Days -3 to -1) during which they will consume an AOLC diet (refer to Diet Manual for details). Dietary oxalate and calcium will be distributed across 3 meals per day, and subjects will maintain this diet until the end of the dosing period.

The researchers plan that March 29, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in October 2022.

Among primary outcome measures are the Safety and tolerability of SYNB8802v1, as assessed by measuring of vital signs and Vital Signs Resting vital signs will be collected as specified in the protocol. Subjects are required to remain in the sitting position for at least 5 minutes prior to obtaining vital signs. A symptom-directed physical examination will be performed by trained medical personnel as specified in the protocol.

The study will take place at the PPD, part of Thermo Fisher Scientific, Austin, Texas, United States.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05377112.

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