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

December 20, 2010
December 22, 2010
October 4, 2011
July 2011
September 2011   (Final data collection date for primary outcome measure)
Tolerability [ Time Frame: 6 days ]
Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.
Same as current
Complete list of historical versions of study NCT01264783 on Archive Site
Biomarkers [ Time Frame: 6 days ]
Analysis of blood samples for various biomarkers
Same as current
Not Provided
Not Provided
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarct
  • Drug: RNS60
    RNS60 for intravenous administration
  • Drug: Placebo
    0.9% normal saline for injection
  • Experimental: RNS60
    Intervention: Drug: RNS60
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2011
September 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Revalesio Corporation
Revalesio Corporation
Not Provided
Principal Investigator: Kelly Craven, M.D. Quintiles, Inc.
Revalesio Corporation
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP