Safety and Tolerability Study of ARC-520 in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.

Official Title
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A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: ARC-520
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Healthy male or female subjects, 18-55 years of age Be a non-smoker Key Exclusion Criteria: History of clinically relevant medical illnesses that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease Acute signs of hepatitis/other infection (e.g., moderate fever, jaundice, nausea, vomiting, abdominal pain) evident within 4 weeks of screening and/or at the screening examination. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of study treatment. Is sero-positive for HIV, HBV, HCV, and/or a history of delta virus hepatitis. Currently uses and/or has a history of alcohol and/or drug abuse < 12 months from screening. Use of investigational agents or devices within 30 days prior to planned study dosing or current participation in an investigational study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARC-520<br>Single dose, intravenous administration of ARC-520. | Drug: ARC-520<br> <br> |
| Placebo Comparator: Normal Saline<br>Single dose, intravenous administration of Normal Saline | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |