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Also known as SYN-020 Delayed Release Capsule
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 oral small molecule being developed for enteritis caused by radiation, a gastrointestinal condition. It is a delayed release capsule formulation. Theriva Biologics, Inc. is developing the drug, which has completed Phase 1 clinical testing in the United States.
SYN-020 is being developed for enteritis caused by radiation, a gastrointestinal injury that can follow radiation exposure. The clinical program has studied the drug in this indication. It remains investigational and has not been approved for commercial use.
SYN-020 targets intestinal alkaline phosphatase, an enzyme. The drug is a small molecule designed to act on this enzyme target in the gastrointestinal tract. This mechanism underlies its development for enteritis caused by radiation.
Theriva Biologics, Inc. is developing SYN-020. The company trades on the Nasdaq under the ticker TOVX. Theriva holds the development program for the delayed release capsule formulation of the drug.
SYN-020 is in Phase 1 development. Two Phase 1 trials have been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication.
SYN-020 has been studied in two completed Phase 1 trials. NCT04815993 evaluated pharmacokinetics, safety, and tolerability with 24 participants. NCT05045833 was a multiple ascending dose study with 40 participants. Both enrolled healthy volunteers in the United States.
Yes. SYN-020 Delayed Release Capsule is another name for SYN-020. The two names refer to the same investigational drug candidate from Theriva Biologics, formulated as an oral delayed release capsule for enteritis caused by radiation.