NCT04984525

Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers

A Phase 1, Dose-escalation, Placebo- and Active-Controlled Crossover Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB1934 and the Effect of Concomitant Proton Pump Inhibitor Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Synlogic · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration.

Detailed description

This study is evaluating the safety, tolerability, kinetics, and pharmacodynamics of SYNB1934 within the following 2 study parts: Part 1 is an inpatient, placebo-controlled, multiple ascending dose (MAD) study in HV male and female subjects in up to 5 dose cohorts (6 treated: 2 placebo) for 5 days of dosing to identify the maximum tolerated dose (MTD). During the second cohort an additional 6 treated subjects will be enrolled; all treated subjects in Cohort 2 will complete a second treatment period with SYNB1618 in a cross-over design. Part 2 is an open-label, randomized sequence, crossover study of SYNB1934 that will be initiated after determination and selection of a well-tolerated dose in Part 1. Subjects will receive treatment with SYNB1934 with a proton pump inhibitor (PPI), will complete a treatment washout period, and receive SYNB1934 treatment without a PPI. Initially 16 HV male and female subjects will be enrolled with the option of expanding Part 2 up to 60 HV subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SYNB1934	SYNB1934 is formulated as a nonsterile solution intended for oral administration
DRUG	SYNB1618	SYNB1618 is formulated as a nonsterile solution intended for oral administration

Timeline

• Start date: 2021-07-02
• Primary completion: 2021-12-10
• Completion: 2021-12-10
• First posted: 2021-07-30
• Last updated: 2022-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study