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 small molecule therapeutic developed by Synlogic, Inc. for urea cycle disorder, a rare disease. It has been studied in a Phase 1 clinical trial. It is not approved by the FDA and remains in clinical development.
SYNB1020 is being developed for the treatment of urea cycle disorder, a rare inherited metabolic condition. The clinical program has evaluated it in healthy volunteers and in the urea cycle disorder setting. It is investigational and has not been approved for any indication.
SYNB1020 is made by Synlogic, Inc., a biotechnology company whose common stock trades on the Nasdaq under the ticker symbol SYBX. Synlogic is the developer responsible for the clinical program for SYNB1020 in urea cycle disorder.
SYNB1020 is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials listed. The program has not advanced beyond Phase 1, and SYNB1020 is not FDA approved.
SYNB1020 has been evaluated in a single Phase 1 trial, NCT03179878, titled Safety and Tolerability of SYNB1020-CP-001. The trial enrolled 52 participants in the United States, was randomized, double-blind, and placebo-controlled, and has been completed.