Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYN-020 · 2 trials · 2 indications
Analysis of SYN-020 level present in blood
Analysis of SYN-020 level present in feces
| Arm | Type | Description |
|---|---|---|
| 5 mg SYN-020 | EXPERIMENTAL | 1 x 5 mg oral capsule, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
| 15 mg SYN-020 | EXPERIMENTAL | 1 x 15 mg oral capsule, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
| 45 mg SYN-020 | EXPERIMENTAL | 3 x 15 mg oral capsules, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
| 75 mg SYN-020 | EXPERIMENTAL | 5 x 15 mg oral capsules, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
| ≤ 75 mg SYN-020 (new formulation) | EXPERIMENTAL | ≤ 5 x 15 mg oral capsules, 14 days, dosing every 12 hours, 6 subjects receive active, 2 subjects receive placebo |
| SYN-020, 5 mg | EXPERIMENTAL | 6 subjects to receive a single 5 mg dose of SYN-020 |
| SYN-020, 15 mg | EXPERIMENTAL | 6 subjects to receive a single 15 mg dose of SYN-020 |
| SYN-020, 45 mg | EXPERIMENTAL | 6 subjects to receive a single 45 mg dose of SYN-020 |
| SYN-020, 150 mg | EXPERIMENTAL | 6 subjects to receive a single 150 mg dose of SYN-020 |
| Name | Type | Description |
|---|---|---|
| SYN-020 Delayed Release Capsule | DRUG | Oral administration (by mouth) |
Inclusion Criteria: 1. Subject is able to read, write, and comprehend English at a sufficient level to understand study-related materials, has provided written informed consent before any study-related procedure was performed, and is willing and able to comply with all testing and study requirement...
SYN-020 is an investigational small molecule being developed for enteritis caused by radiation, a gastrointestinal condition. It is currently in Phase 1 clinical development and has not been approved by the FDA.
SYN-020 is being developed by Theriva Biologics, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol TOVX.
SYN-020 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and the drug remains investigational, meaning it has not received FDA approval.
SYN-020 has been studied in two completed Phase 1 trials: NCT04815993, which assessed pharmacokinetics, safety, and tolerability in 24 participants, and NCT05045833, a multiple ascending dose study in 40 participants. Both trials were conducted in the United States.
Yes, SYN-020 is also referred to as SYN 020 in clinical trial documentation. Both names refer to the same investigational drug developed by Theriva Biologics for radiation-induced enteritis.