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A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PORT-77 | Experimental | Healthy adult participants will receive PORT 77. |
|
| Placebo | Placebo Comparator | Healthy adult participants will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PORT-77 | Drug | Healthy adult participants will receive PORT 77. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I) | Day 8 | |
| Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II and III) | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of a single-dose of PORT-77 (Part I) | Day 8 | |
| Plasma concentration of the steady-state of PORT-77 (Part II and III) | Day 21 | |
| Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Portal Therapeutics, Chief Medical Officer | Portal Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| Placebo |
| Drug |
Healthy adult participants will receive matching placebo. |
|
| Day 4 |
| Evaluate effects of single doses of PORT-77 on ECG parameters (Part I) | Day 8 |
| Evaluate effects of multiple doses of PORT-77 on ECG parameters (Part II and III) | Day 21 |