SYNB1353 for Homocystinuria

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
High Point Clinical Trials Center, High Point, NC
Homocystinuria
SYNB1353 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized, dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the safety, tolerability, and PD of SYNB1353 in HVs.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Day -2 through Day 8

Day 8
Number of participants with abnormal laboratory values and/or adverse events
Week 14
The rate at which the SYNB1353 strain clears

Trial Safety

Trial Design

8 Treatment Groups

Cohort 7
1 of 8
Cohort 3
1 of 8
Cohort 2
1 of 8
Cohort 1
1 of 8
Cohort 4
1 of 8
Cohort 8
1 of 8
Cohort 5
1 of 8
Cohort 6
1 of 8
Experimental Treatment

64 Total Participants · 8 Treatment Groups

Primary Treatment: SYNB1353 · No Placebo Group · Phase 1

Cohort 7
Drug
Experimental Group · 1 Intervention: SYNB1353 · Intervention Types: Drug
Cohort 3
Drug
Experimental Group · 1 Intervention: SYNB1353 · Intervention Types: Drug
Cohort 2
Drug
Experimental Group · 1 Intervention: SYNB1353 · Intervention Types: Drug
Cohort 1
Drug
Experimental Group · 1 Intervention: SYNB1353 · Intervention Types: Drug
Cohort 4
Drug
Experimental Group · 1 Intervention: SYNB1353 · Intervention Types: Drug
Cohort 8
Drug
Experimental Group · 1 Intervention: SYNB1353 · Intervention Types: Drug
Cohort 5
Drug
Experimental Group · 1 Intervention: SYNB1353 · Intervention Types: Drug
Cohort 6
Drug
Experimental Group · 1 Intervention: SYNB1353 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day -2 through day 8
Closest Location: High Point Clinical Trials Center · High Point, NC
2012First Recorded Clinical Trial
1 TrialsResearching Homocystinuria
35 CompletedClinical Trials

Who is running the clinical trial?

SynlogicLead Sponsor
8 Previous Clinical Trials
420 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You agree to all study procedures, including stool, urine, and blood collection and follow-up visits, and compliance with all study procedures.
You are not breastfeeding.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.