Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy, Enteric Hyperoxaluria
In brief
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).
Key facts
- Study ID
- NCT04629170
- Run by
- Synlogic
- People needed
- 77
- Starts
- 2020-11-04
- Expected to finish
- 2023-01-17
- Last updated by the study team
- 2024-03-08
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: accepted.
Where it is running
- Urological Associates of Southern Arizona (open to remote participation) — Tucson, Arizona, United States
- Genesis Clinical Research — Tampa, Florida, United States
- Knoxville Kidney Center — Knoxville, Tennessee, United States
- PRA Health Sciences — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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