Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYNB1020 · 1 trial · 2 indications
Will be measured by assessing nature and frequency of AEs, Laboratory Assessments, and ECGs
| Arm | Type | Description |
|---|---|---|
| SYNB1020 | EXPERIMENTAL | SYNB1020 |
| Placebo | PLACEBO_COMPARATOR | 100 mL masking solution |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| SYNB1020 | DRUG | Investigational Product |
Key Inclusion Criteria: * Age 18 to 64 years * Healthy volunteer Males and Females; Females must be of non childbearing potential * Able and willing to complete informed consent process * Available for and agree to all study procedures * Screening Labs within normal range Key Exclusion Criteria: ...
SYNB1020 is an investigational drug being studied for use in healthy volunteers and for urea cycle disorder. It is a small molecule being developed by Synlogic, Inc. As of now, it is in Phase 1 clinical development and is not approved by the FDA.
SYNB1020 is being developed by Synlogic, Inc., a biopharmaceutical company. The company's ticker symbol is SYBX. The drug is currently in Phase 1 clinical trials and is not yet approved for commercial use.
SYNB1020 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA. The drug is being studied for safety and tolerability in healthy volunteers and for urea cycle disorder.
SYNB1020 has one completed Phase 1 clinical trial with the identifier NCT03179878. The trial, titled 'Safety and Tolerability of SYNB1020-CP-001', enrolled 52 participants in the United States. It was a randomized, double-blind, placebo-controlled study involving healthy volunteers.
No, SYNB1020 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied for safety and tolerability, and it has not yet completed the clinical trials required for regulatory approval.