Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05462132 | Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers | PHASE1 | COMPLETED | 31 | — | — | Jul 7, 2022 | Nov 27, 2022 | Mar 17, 2023 | 1 | United States |
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...