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This is a single-center, randomized, double-blind, placebo-controlled, ascending multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo. Subjects will be dosed daily for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIA-3196 | Experimental |
| |
| Placebo | Placebo Comparator | Multiple, ascending dosing groups (cohorts) will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events as a measure of safety and tolerability of VIA-3196 | Evaluation will start from predose (Day -1) until the follow-up visit (Day 21) | up to 22 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of VIA-3196 | Assessed without food | 0 to 24 hours on Day 1 and Day 14 |
| Lipid level changes following administration of VIA-3196 | Day 1 to 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Taub, MD | Madrigal Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRACS Institute (formerly Cetero Research) | Fargo | North Dakota | 58104 | United States |
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| VIA-3196 | Drug | Oral, daily dosing for 14 days |
|