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Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers — HCU  

Homocystinuria Clinical Trial

Official title:
A Phase 1, Dose-escalation, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB1353 in Healthy Volunteers

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05462132
Study type Interventional
Source Synlogic
Contact
Status Completed
Phase Phase 1
Start date July 7, 2022
Completion date November 27, 2022
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