Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarct
• Intervention / Treatment: Drug: RNS60; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Quintiles, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; 0.9% normal saline for injection
EXPERIMENTAL: RNS60	Drug: RNS60; RNS60 for intravenous administration

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

Collaborators and Investigators

• Sponsor: Revalesio Corporation
• Investigators: Principal Investigator: Kelly Craven, M.D., Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (ESTIMATE): December 22, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 4, 2011
• Last Update Submitted That Met QC Criteria: September 30, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Myocardial Infarction; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Pharmaceutical Solutions; RNS60
• Other Study ID Numbers: 11.1.1.H1