Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2011

Interventions

  • Drug: RNS60
    • RNS60 for intravenous administration
  • Drug: Placebo
    • 0.9% normal saline for injection

Arms, Groups and Cohorts

  • Experimental: RNS60
    • RNS60
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Tolerability
    • Time Frame: 6 days
    • Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.

Secondary Measures

  • Biomarkers
    • Time Frame: 6 days
    • Analysis of blood samples for various biomarkers

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Revalesio Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kelly Craven, M.D., Principal Investigator, Quintiles, Inc.

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