Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYNB8802 · 1 trial · 2 indications
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, ...
SYNB8802 is being developed for enteric hyperoxaluria, a condition marked by excessive oxalate absorption in the digestive tract. It is an investigational small molecule therapeutic from Synlogic, Inc. that has completed a Phase 1 clinical trial in healthy adult volunteers and adults with enteric hyperoxaluria.
SYNB8802 is being developed by Synlogic, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol SYBX. Synlogic is responsible for the clinical program evaluating SYNB8802 in enteric hyperoxaluria.
SYNB8802 is in Phase 1 clinical development. The program has completed one Phase 1 trial (NCT04629170) that enrolled 77 participants. No active trials are currently listed for SYNB8802, and the drug remains investigational.
SYNB8802 has been studied in a single completed Phase 1 trial, NCT04629170, titled "Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria." The trial enrolled 77 participants in the United States and was randomized, double-blind, and placebo-controlled.
SYNB8802 is not approved; it is an investigational drug still in clinical development. The only completed study is a Phase 1 trial (NCT04629170) that assessed safety and tolerability in healthy volunteers and adults with enteric hyperoxaluria.