Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYNB1934 · 1 trial · 1 indication
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 |
|---|---|---|
| Part 1 Cohort 1 MAD HV: SYNB1934 (3 x 10^11 live cells) | EXPERIMENTAL | HV subjects receive SYNB1934 (3 x 10\^11 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 2 Crossover HV: SYNB1934 (6 x 10^11 live cells) | EXPERIMENTAL | HV subjects receive SYNB1934 (6 x 10\^11 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Following a ≥ 7-day washout period HV subjects receive SYNB1618 (6 x 10\^11 live cells), at least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 3 MAD HV: SYNB1934 (1 x 10^12 live cells) | EXPERIMENTAL | HV subjects receive SYNB1934 (1 x 10\^12 live cells) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 4 MAD HV: SYNB1934 (optional) | EXPERIMENTAL | HV subjects receive SYNB1934 (at a dose to be determined based on the data from the first 3 cohorts) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 1 Cohort 5 MAD HV: SYNB1934 (optional) | EXPERIMENTAL | HV subjects receive SYNB1934 (at a dose to be determined based on the data from the first 3 cohorts) At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Part 2 Crossover with PPI vs No PII | EXPERIMENTAL | HV subjects receive SYNB1934 (at or below the MTD from Part 1) with PPI At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 Following a ≥ 14-day washout period HV subjects receive SYNB1934 (at or below the MTD from Part 1) without PPI At least 3 times per day (TID) on Treatment Day 1 and once at breakfast on Treatment Day 2 |
| Name | Type | Description |
|---|---|---|
| SYNB1934 | DRUG | SYNB1934 is formulated as a nonsterile solution intended for oral administration |
| SYNB1618 | DRUG | SYNB1618 is formulated as a nonsterile solution intended for oral administration |
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...
SYNB1934 is an investigational drug being studied in healthy adult volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its safety and tolerability. The drug is being developed by Synlogic, Inc. and has received FDA orphan drug designation for rare pediatric diseases.
SYNB1934 is being developed by Synlogic, Inc., a biopharmaceutical company traded on NASDAQ under the ticker SYBX. The company is conducting clinical research on this investigational drug, which is currently in Phase 1 development.
SYNB1934 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug is not yet approved by the FDA. It remains an investigational agent under study for use in healthy volunteers.
SYNB1934 has one completed clinical trial, NCT04984525, titled "Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers." This Phase 1 study enrolled 106 participants in the United States and was a randomized, double-blind, controlled trial.
SYNB1934 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The FDA has granted it orphan drug designation for rare pediatric diseases, but it has not completed the approval process.