Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and tolerability of RNS60 administered intravenously to healthy subjects. 12 subjects will receive RNS60 or placebo at three escalating rates for 48 hours for each rate.

Official Title
-----------------
Phase I, Double-blind, Randomized, Placebo-controlled, Single-center Study to Assess the Safety and Tolerability of RNS60 Administered Intravenously to Healthy Subjects

Conditions
-----------------
Myocardial Infarct

Intervention / Treatment
-----------------
* Drug: RNS60
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males between 18-55 years Minimum body weight of 60 kg BMI of 18-32 kg/m2 Able to execute informed written consent Exclusion Criteria: A chronic or acute disease that might interfere with the evaluation of the safety of RNS60 Current or prior malignancies (excluding history of treated non-melanoma skin carcinoma) Positive viral serology test for HBsAG, Hep C antibody, Hep A IgM, or HIV Use of any prescription medications within 2 weeks of the first day of dosing Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, GI, endocrine or metabolic Treatment with monoclonal antibody therapy within 5 half-lives prior to the first dose of study medication Treatment with any investigational drugs or therapies within 30 days (or 5 half-lives, whichever is greater) prior to the first dose of study medication Abnormal pre-admission vital signs, physical exam, clinical laboratory, or any safety variable considered clinically significant for this population by the PI Subject is considering or has scheduled any surgical procedure during participation in study History of alcohol and/or dug abuse within 1 year prior to first dose of study medication Subject has donated plasma or blood within 30 days prior to first dose of study medication Subject requires treatment with any medications, either prescription or nonprescription, including dietary supplements or herbal medications, within 14 days prior to the first dose of study medication. Exceptions are nonprescription topical medications (that are not systemically absorbed), acetaminophen, or vitamins at recommended daily doses (not mega dose vitamins) A positive qualitative urine drug or alcohol test Concurrent enrollment in any other clinical trial Subject is judged by PI or Medical Monitor to be inappropriate for the study - Subject has Gilbert's syndrome Subject has estimated creatinine clearance at screening of <90 mL/min.

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RNS60<br>RNS60 | Drug: RNS60<br>* RNS60 for intravenous administration<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 0.9% normal saline for injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability | Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers. | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers | Analysis of blood samples for various biomarkers | 6 days |