Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SXC-2023 | Experimental | Dose Escalation |
|
| Placebo | Placebo Comparator | Dose Escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SXC-2023 | Drug | Oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related adverse events | Treatment related adverse events as a measure of safety and tolerability of SXC-2023 following multiple ascending doses | 18 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Assessments: Cmax | Peak plasma concentration | Up to 96 hr post dose |
| Pharmacokinetic Assessments: Tmax | Time to peak plasma concentration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tricia Cotter | Promentis Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo |
|
| Up to 96 hr post dose |
| Pharmacokinetic Assessments: AUC | Area under the plasma concentration-time curve | Up to 96 hr post dose |