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NCT04629170 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
A Phase 1 study of Healthy and Enteric Hyperoxaluria, sponsored by Synlogic.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 4
- Study locations
NCT04629170: Completed Phase 1 study of Healthy and Enteric Hyperoxaluria, sponsored by Synlogic.
NCT04629170 is a Phase 1 study of Healthy and Enteric Hyperoxaluria that has completed, run by Synlogic. The registered enrollment target is 77 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04629170, a Phase 1 study of Healthy and Enteric Hyperoxaluria, has completed, sponsored by Synlogic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 4
- Study locations
Study 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).
Primary Outcome
Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, electrocardiograms, and any other medically indicated assessments from the time informed consent is signed through the end of the safety follow-up period. AEs are considered to be treatment emergent (TEAE) if they occur or worsen in severity after th
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SYNB8802
Study Locations (4)
Arizona
- Urological Associates of Southern Arizona (open to remote participation) - Tucson
Florida
- Genesis Clinical Research - Tampa
Tennessee
- Knoxville Kidney Center - Knoxville
Utah
- PRA Health Sciences - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2023-01-17 |
| Phase | Phase 1 |
What the finished NCT04629170 record still lists
NCT04629170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04629170 reports a single indexed study location in Arizona, Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04629170 about?
NCT04629170 is a clinical study titled "Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria". 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 monitori...
What is the current status of trial NCT04629170?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2020-11-04. Estimated completion is 2023-01-17.
What conditions does trial NCT04629170 study?
This clinical trial studies the following conditions: Healthy, Enteric Hyperoxaluria.
What interventions are being tested in trial NCT04629170?
The interventions under investigation include: Placebo (DRUG), SYNB8802 (DRUG).
Who is sponsoring clinical trial NCT04629170?
This trial is sponsored by Synlogic, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04629170 being conducted?
This trial has 4 study locations across Arizona, Florida, Tennessee, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04629170's enrollment target sits among peer trials
77 291st of 1090 higher than 797 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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