NCT04629170

Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria

A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB8802 in Healthy Volunteers and in Patients With Enteric Hyperoxaluria

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Synlogic · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

Summary

This Phase 1a/b, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB8802 in healthy volunteers (HV) and subjects diagnosed with enteric hyperoxaluria (EH). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration. In Part 2, all evaluations and assessments throughout this study may be conducted either at the clinical site or by a home healthcare professional at an alternative location (e.g., EH patient's home, hotel).

Detailed description

This study is evaluating the safety, tolerability, kinetics, and pharmacodynamics of SYNB8802 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: 3 placebo) for 5 days of dosing to identify the maximum tolerated dose (MTD). Part 2 is a placebo-controlled crossover study in up to 20 adult male and female subjects with EH secondary to Roux-en-Y bariatric surgery. Subjects will be randomized to receive either SYNB8802 (at or below the MTD from Part 1) or placebo for six days before crossing over to receive either placebo or SYNB8802 for another six days, respectively. This part of the study has been designed with the flexibility of being able to be conducted either at the clinical site or by a home healthcare professional at an alternative location (e.g., patient's home, hotel).

Conditions

• Healthy
• Enteric Hyperoxaluria

Interventions

Type	Name	Description
DRUG	SYNB8802	SYNB8802 is formulated as a nonsterile solution intended for oral administration
DRUG	Placebo	In order to maintain study blinding, matching placebo in identical packaging will be manufactured using an inactive powder

Timeline

• Start date: 2020-11-04
• Primary completion: 2023-01-17
• Completion: 2023-01-17
• First posted: 2020-11-16
• Last updated: 2024-03-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study