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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

December 20, 2010
September 30, 2011
July 2011
September 2011   (final data collection date for primary outcome measure)
Tolerability [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.
Same as current
Complete list of historical versions of study NCT01264783 on ClinicalTrials.gov Archive Site
Biomarkers [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarct
  • Drug: RNS60
    RNS60 for intravenous administration
  • Drug: Placebo
    0.9% normal saline for injection
  • Experimental: RNS60
    RNS60
    Intervention: Drug: RNS60
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01264783
11.1.1.H1
No
Revalesio Corporation
Revalesio Corporation
Not Provided
Principal Investigator: Kelly Craven, M.D. Quintiles
Revalesio Corporation
September 2011

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