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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
No Placebo-Only Group

Summary

This trial is testing a new drug called SYNB1353 on healthy volunteers to see if it is safe and well-tolerated. Researchers are also studying how the drug affects levels of methionine, an amino acid, in the body.

Eligible Conditions
  • Homocystinuria

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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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
426 Total Patients Enrolled
~9 spots leftby Nov 2025
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