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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARC-520 | Experimental | Single dose, intravenous administration of ARC-520. |
|
| Normal Saline | Placebo Comparator | Single dose, intravenous administration of Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC-520 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the incidence and frequency of adverse events as a measure of safety and tolerability of ARC-520 | The incidence and frequency of adverse events (AEs), serious adverse events (SAEs), related AEs, related SAEs, and AEs leading to withdrawal, dose modification, or treatment discontinuation will be summarized by dose and treatment group. | One month |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of ARC-520 at different dose concentrations | Plasma concentrations following a single dose of ARC-520 at different dose levels will be used to calculate the following ARC-520 pharmacokinetic parameters: Cmax, tmax, AUC0-24, AUCinf, and t1/2. Descriptive statistics of pharmacokinetic parameters will include mean, standard deviation, and coefficient of variation. | 2 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Lickliter, MD, PhD | Nucleus Network Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 1 | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| C000717093 | ARC-520 |
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