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Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01264783
Recruitment Status : Completed
First Posted : December 22, 2010
Last Update Posted : October 4, 2011
Information provided by (Responsible Party):
Revalesio Corporation

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarct Drug: RNS60 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: RNS60
Drug: RNS60
RNS60 for intravenous administration

Placebo Comparator: Placebo
Drug: Placebo
0.9% normal saline for injection

Primary Outcome Measures :
  1. Tolerability [ Time Frame: 6 days ]
    Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.

Secondary Outcome Measures :
  1. Biomarkers [ Time Frame: 6 days ]
    Analysis of blood samples for various biomarkers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01264783

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United States, Kansas
Quintiles, Inc.
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Revalesio Corporation
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Principal Investigator: Kelly Craven, M.D. Quintiles, Inc.

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Responsible Party: Revalesio Corporation Identifier: NCT01264783     History of Changes
Other Study ID Numbers: 11.1.1.H1
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
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