Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05045833 | Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020 | PHASE1 | COMPLETED | 40 | — | — | Oct 18, 2021 | Mar 21, 2022 | Apr 21, 2022 | 1 | United States |
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 |
| 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...