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Probiotic Therapy

SYNB1353 for Homocystinuria (HCU Trial)

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -2 through day 8
Awards & highlights

HCU Trial Summary

This trial is testing a new drug to see if it is safe and effective. The trial is blinded, meaning participants don't know if they are receiving the drug or a placebo. The trial is also dose-escalation, meaning that participants will receive different doses of the drug to see what is the best and safest dose.

HCU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -2 through day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and day -2 through day 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with abnormal laboratory values and/or adverse events
Secondary outcome measures
Muscle strain

HCU Trial Design

8Treatment groups
Experimental Treatment
Group I: Cohort 8Experimental Treatment1 Intervention
HV subjects receive doses less than or equal to 2 × 10^12 live cells of SYNB1353 and up to 100 mg/kg of methionine. Subjects will receive a single dose of SYNB1353 on the first day of dosing (Day 1), on Days 2 and 3 subjects will receive up to 2 doses of IMP (BID), and on Days 4 to 7 subjects will receive up to 3 doses of IMP (TID). A methionine loading study will be performed on Day -1 and Day 7 after an overnight fast. A dose of methionine of up to 100 mg/kg will be evaluated.
Group II: Cohort 7Experimental Treatment1 Intervention
HV subjects receive doses less than or equal to 2 × 10^12 live cells of SYNB1353 and 30 mg/kg of methionine. Subjects will receive a single dose of SYNB1353 on the first day of dosing (Day 1), on Days 2 and 3 subjects will receive up to 2 doses of IMP (BID), and on Days 4 to 7 subjects will receive up to 3 doses of IMP (TID). A methionine loading study will be performed on Day -1 and Day 7 after an overnight fast. A dose of methionine of 30 mg/kg will be evaluated.
Group III: Cohort 6Experimental Treatment1 Intervention
HV subjects receive doses 1 × 10^12 live cells of SYNB1353 and up to 100 mg/kg of methionine. Subjects will receive a single dose of SYNB1353 on the first day of dosing (Day 1), on Days 2 and 3 subjects will receive up to 2 doses of IMP (BID), and on Days 4 to 7 subjects will receive up to 3 doses of IMP (TID). A methionine loading study will be performed on Day -1 and Day 7 after an overnight fast. A dose of methionine of up to 100 mg/kg will be evaluated.
Group IV: Cohort 5Experimental Treatment1 Intervention
HV subjects receive doses 1 × 10^12 live cells of SYNB1353 and 30 mg/kg of methionine. Subjects will receive a single dose of SYNB1353 on the first day of dosing (Day 1), on Days 2 and 3 subjects will receive up to 2 doses of IMP (BID), and on Days 4 to 7 subjects will receive up to 3 doses of IMP (TID). A methionine loading study will be performed on Day -1 and Day 7 after an overnight fast. A dose of methionine of 30 mg/kg will be evaluated.
Group V: Cohort 4Experimental Treatment1 Intervention
HV subjects receive doses 6 × 10^11 live cells of SYNB1353 and up to 100 mg/kg of methionine. Subjects will receive a single dose of SYNB1353 on the first day of dosing (Day 1), on Days 2 and 3 subjects will receive up to 2 doses of IMP (BID), and on Days 4 to 7 subjects will receive up to 3 doses of IMP (TID). A methionine loading study will be performed on Day -1 and Day 7 after an overnight fast. A dose of methionine of up to 100 mg/kg will be evaluated.
Group VI: Cohort 3Experimental Treatment1 Intervention
HV subjects receive doses 6 × 10^11 live cells of SYNB1353 and 30 mg/kg of methionine. Subjects will receive a single dose of SYNB1353 on the first day of dosing (Day 1), on Days 2 and 3 subjects will receive up to 2 doses of IMP (BID), and on Days 4 to 7 subjects will receive up to 3 doses of IMP (TID). A methionine loading study will be performed on Day -1 and Day 7 after an overnight fast. A dose of methionine of 30 mg/kg will be evaluated.
Group VII: Cohort 2Experimental Treatment1 Intervention
HV subjects receive doses 3 × 10^11 live cells of SYNB1353 and up to 100 mg/kg of methionine. Subjects will receive a single dose of SYNB1353 on the first day of dosing (Day 1), on Days 2 and 3 subjects will receive up to 2 doses of IMP (BID), and on Days 4 to 7 subjects will receive up to 3 doses of IMP (TID). A methionine loading study will be performed on Day -1 and Day 7 after an overnight fast. A dose of methionine of up to 100 mg/kg will be evaluated.
Group VIII: Cohort 1Experimental Treatment1 Intervention
HV subjects receive doses 3 × 10^11 live cells of SYNB1353 and 30 mg/kg of methionine. Subjects will receive a single dose of SYNB1353 on the first day of dosing (Day 1), on Days 2 and 3 subjects will receive up to 2 doses of IMP (BID), and on Days 4 to 7 subjects will receive up to 3 doses of IMP (TID). A methionine loading study will be performed on Day -1 and Day 7 after an overnight fast. A dose of methionine of 30 mg/kg will be evaluated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SYNB1353
2022
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SynlogicLead Sponsor
9 Previous Clinical Trials
469 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any availabilities in this research study for participants?

"According to clinicaltrials.gov, this research endeavour is currently enrolling participants and has been live since July 7th 2022; the details were last revised on November 2nd of that same year."

Answered by AI

Who is the ideal participant for this clinical trial?

"This clinical trial is enlisting 64 people diagnosed with homocystinuria, aged between 18 and 64. To be considered for inclusion in the study, candidates must fulfill specific criteria: over 18 years old but no older than 64; they must agree to the informed consent process, participate in all required research procedures (including collecting feces, urine, and blood samples), comply with diet control measures as well as follow-up visits; male subjects need to practice sexual abstinence or undergo a vasectomy (or use an appropriate form of contraception alongside their female partners); women of childbearing potential should have negative pregnancy tests at screening and baseline prior to beginning"

Answered by AI

Are elderly participants being accepted in this trial?

"To be eligible for the clinical trial, potential participants must fall in 18 to 64-year age range. For those outside of this bracket there are other trials available: 1 study catering to minors and another specifically targeting seniors over 65 years old."

Answered by AI

What is the numerical scope of this research project?

"Affirmative. Clinicaltrials.gov data reflects that this research study is currently recruiting patients, having been first posted on July 7th 2022 and updated recently on November 2nd of the same year. The investigators need to recruit 64 individuals from one medical centre for this trial."

Answered by AI

Has the FDA sanctioned SYNB1353 for medicinal use?

"Due to the fact that SYNB1353 is in a Phase 1 trial with limited data supporting its efficacy and safety, it was given a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
High Point Clinical Trials Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers
2022. "Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05462132.
~11 spots leftby Apr 2025
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