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Microbial Therapy

SYNB8802v1 for Enteric Hyperoxaluria

Phase < 1
Waitlist Available
Research Sponsored by Synlogic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 43 days
Awards & highlights

Study Summary

This trial is testing a new medication to see if it's safe and effective at reducing oxalate levels in people who have had gastric bypass surgery or short-bowel syndrome.

Eligible Conditions
  • Enteric Hyperoxaluria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~43 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 43 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of SYNB8802v1 by assessing clinical laboratory tests
Safety and tolerability of SYNB8802v1, as assessed by AEs, clinical laboratory tests, and vital sign measurements
Safety and tolerability of SYNB8802v1, as assessed by measuring of vital signs
Secondary outcome measures
Change from baseline in 24-hour excreted UOx among SYNB8802v1-treated subjects versus those treated with placebo.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SYNB8802v1Experimental Treatment1 Intervention
Dose ramp to 1 × 1011 QD and then dose ramp to 3 × 1011 TID SYNB8802v1 live cells
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered during the dose ramp such that all subjects receive IMP dosing TID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SYNB8802v1
2022
Completed Early Phase 1
~20

Find a Location

Who is running the clinical trial?

SynlogicLead Sponsor
9 Previous Clinical Trials
489 Total Patients Enrolled
1 Trials studying Enteric Hyperoxaluria
77 Patients Enrolled for Enteric Hyperoxaluria

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome
2022. "Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05377112.
~4 spots leftby Apr 2025
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