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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04629170 | Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria | PHASE1 | COMPLETED | 77 | — | — | Nov 4, 2020 | Jan 17, 2023 | Mar 8, 2024 | 4 | United States |
Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, electrocardiograms, and any other medically indicated assessments from the time informed consent is signed through the end of the safety follow-up period. AEs are considered to be treatment emergent (TEAE) if they occur or worsen in severity after the first dose of study treatment. TEAEs are considered treatment-related if relationship to study drug is possibly related, probably related, or definitely related.
| Arm | Type | Description |
|---|---|---|
| MAD HV: SYNB8802 (1 x 10^11 live cells) | EXPERIMENTAL | HV subjects receive SYNB8802 (1 x 10\^11 live cells) TID for 5 days in the MAD study (Part 1). |
| MAD HV: SYNB8802 (3 x 10^11 live cells) | EXPERIMENTAL | HV subjects receive SYNB8802 (3 x 10\^11 live cells) TID for 5 days in the MAD study (Part 1). |
| MAD HV: SYNB8802 (1 x 10^12 live cells) | EXPERIMENTAL | HV subjects receive SYNB8802 (1 x 10\^12 live cells) TID for 5 days in the MAD study (Part 1). |
| MAD HV: SYNB8802 (optional cohort 1) | EXPERIMENTAL | HV subjects receive SYNB8802 (at a dose to be determined based on the data from the first 3 cohorts) TID for 5 days in the MAD study (Part 1). |
| MAD HV: SYNB8802 (optional cohort 2) | EXPERIMENTAL | HV subjects receive SYNB8802 (at a dose to be determined based on the data from the first 3 cohorts) TID for 5 days in the MAD study (Part 1). |
| MAD HV: Placebo | PLACEBO_COMPARATOR | HV subjects receive placebo TID for 5 days in the MAD study (Part 1). |
| Crossover Arm 1: SYNB8802 crossover to Placebo | OTHER | In Part 2 subjects will be randomized (1:1) to receive SYNB8802 TID for 6 days and then, following a washout period, receive Placebo TID for 6 days. |
| Crossover Arm 2: Placebo crossover to SYNB8802 | OTHER | In Part 2 subjects will be randomized (1:1) to receive Placebo TID for 6 days and then, following a washout period, receive SYNB8802 TID for 6 days. |
| Name | Type | Description |
|---|---|---|
| SYNB8802 | DRUG | SYNB8802 is formulated as a nonsterile solution intended for oral administration |
| Placebo | DRUG | In order to maintain study blinding, matching placebo in identical packaging will be manufactured using an inactive powder |
Part 1 Inclusion Criteria: 1. Age ≥ 18 to ≤ 64 years. 2. Body mass index (BMI) 18.5 to 28 kg/m2. 3. Able and willing to voluntarily complete the informed consent process. 4. Available for and agree to all study procedures, including feces, urine, and blood collection and adherence to diet control, ...