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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05377112 | Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome | EARLY_PHASE1 | COMPLETED | 11 | — | — | Mar 29, 2022 | Dec 7, 2022 | Mar 17, 2023 | 1 | United States |
Vital Signs Resting vital signs will be collected as specified in the protocol. Subjects are required to remain in the sitting position for at least 5 minutes prior to obtaining vital signs. A symptom-directed physical examination will be performed by trained medical personnel as specified in the protocol.
The clinical laboratory tests listed in the protocol will be performed at the time points specified in the protocol's schedule of assessments.
Adverse events will be assessed continuously by direct observation and subject event recording and interviews. The severity of AEs will be evaluated using the NCI CTCAE, version 5.0 criteria.
| Arm | Type | Description |
|---|---|---|
| SYNB8802v1 | EXPERIMENTAL | Dose ramp to 1 × 1011 QD and then dose ramp to 3 × 1011 TID SYNB8802v1 live cells |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered during the dose ramp such that all subjects receive IMP dosing TID |
| Name | Type | Description |
|---|---|---|
| SYNB8802v1 | DRUG | SYNB8802v1 is an orally administered, non-systemically absorbed live biotherapeutic developed for the treatment of EH. The strain converts oxalate to formate and CO2, two naturally occurring GI metabolites. SYNB8802 was developed by engineering a pathway for oxalate degradation in a probiotic strain of Escherichia coli Nissle 1917 (EcN). It is intended to act within the GI tract to reduce the oxalate levels in patients with EH by converting oxalate to formate and CO2, two naturally occurring GI metabolites. |
| Placebo | OTHER | placebo powder will be aliquoted into high density polyethylene (HDPE) bottles and diluted in the same formulation buffer as SYNB8802v1 lyophilized powder. The placebo consists of corn starch and dyes to color match the placebo to the SYNB8802v1 powder for oral suspension |
Inclusion Criteria: * Age ≥ 18 to ≤ 74 years. * Able and willing to voluntarily complete the informed consent process. * Available for, and agree to, all study procedures, including fixed diet, feces, urine, and blood * collection, follow-up visits, and compliance with all study procedures. * Histo...