Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYNB1353 · 1 trial · 1 indication
Lab results outside of the central laboratory normal range parameters will be considered abnormal and reviewed for clinical significance and reported as AEs. AEs will be evaluated using the NCI CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 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. |
| Cohort 2 | EXPERIMENTAL | 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. |
| Cohort 3 | EXPERIMENTAL | 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. |
| Cohort 4 | EXPERIMENTAL | 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. |
| Cohort 5 | EXPERIMENTAL | 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. |
| Cohort 6 | EXPERIMENTAL | 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. |
| Cohort 7 | EXPERIMENTAL | 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. |
| Cohort 8 | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| SYNB1353 | DRUG | SYNB1353 IMP is formulated as a nonsterile solution intended for oral administration. SYNB1353 is subsequently lyophilized to form the bulk drug product. The lyophilized product is sieved into powder form and filled into high-density polyethylene (HDPE) bottles. Placebo will be manufactured using an inactive powder that is color matched to the SYNB1353 drug product. L-Methionine will be supplied as dry powder and will be suspended in a diluent prior to use. |
Inclusion Criteria: 1. Age ≥ 18 to ≤ 64 years. 2. Able and willing to voluntarily complete the informed consent process. 3. Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, inpatient monitoring, follow-up visits, and compli...
SYNB1353 is an investigational small molecule being developed for the treatment of homocystinuria, a rare inherited metabolic disorder. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug has received a rare pediatric disease designation from the FDA.
SYNB1353 is being developed by Synlogic, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker SYBX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for homocystinuria.
SYNB1353 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received a rare pediatric disease designation, which may provide incentives for development, but it remains in early-stage clinical testing.
SYNB1353 has one completed Phase 1 clinical trial, NCT05462132, titled 'Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers.' This randomized, double-blind, controlled study enrolled 31 participants in the United States and included healthy volunteers aged 18 years and older.
No alternative names for SYNB1353 have been disclosed. The drug is identified solely by its code name SYNB1353 in clinical trial records and by the developer, Synlogic, Inc. It is not known to be marketed under any other brand name.