Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Enteric Hyperoxaluria
- Healthy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Part 1 - randomized, placebo-controlled multiple-dose escalation Part 2 - randomized, placebo-controlled crossoverMasking: Triple (Participant, Care Provider, Investigator)Masking Description: Double-blind (Sponsor-open)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 74 years
- Gender
- Both males and females
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 o...
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).
Tracking Information
- NCT #
- NCT04629170
- Collaborators
- Not Provided
- Investigators
- Not Provided