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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04629170
The ClinicalTrials.gov registry entry for NCT04629170 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The listed sponsor is Synlogic, which has 10 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.