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Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Revalesio Corporation
ClinicalTrials.gov Identifier:
NCT01264783
First received: December 20, 2010
Last updated: September 30, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Myocardial Infarct
 Drug: RNS60
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by Revalesio Corporation:

Primary Outcome Measures:
  • Tolerability [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
    Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.


Secondary Outcome Measures:
  • Biomarkers [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
    Analysis of blood samples for various biomarkers


Enrollment: 12
Study Start Date: July 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RNS60
RNS60
 Drug: RNS60
RNS60 for intravenous administration
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
0.9% normal saline for injection

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264783

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

No publications provided

Responsible Party: Revalesio Corporation
ClinicalTrials.gov Identifier: NCT01264783     History of Changes
Other Study ID Numbers: 11.1.1.H1
Study First Received: December 20, 2010
Last Updated: September 30, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013