This study is evaluating the safety, tolerability and PD of SYNB1353 in up to 8 cohorts of HVs. In each cohort, HVs will be randomly assigned to investigational medicinal product (IMP), according to a MAD design, to receive either SYNB1353 or placebo (6 active:2 placebo per cohort). A methionine loading study will be performed on Day -1 and Day 7. At each IMP dose level, a dose of methionine will be evaluated. The methionine dose may increase if necessary to evaluate the PD of SYNB1353.
This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized, dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the safety, tolerability, and PD of SYNB1353 in HVs.