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Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

Primary Purpose

Myocardial Infarct

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RNS60
Placebo
Sponsored by
Revalesio Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarct

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Quintiles, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RNS60

Placebo

Arm Description

RNS60

Placebo

Outcomes

Primary Outcome Measures

Tolerability
Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.

Secondary Outcome Measures

Biomarkers
Analysis of blood samples for various biomarkers

Full Information

First Posted
December 20, 2010
Last Updated
September 30, 2011
Sponsor
Revalesio Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01264783
Brief Title
Safety and Tolerability of RNS60 Given by IV to Healthy Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Revalesio Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarct

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RNS60
Arm Type
Experimental
Arm Description
RNS60
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
RNS60
Intervention Description
RNS60 for intravenous administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% normal saline for injection
Primary Outcome Measure Information:
Title
Tolerability
Description
Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Biomarkers
Description
Analysis of blood samples for various biomarkers
Time Frame
6 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Craven, M.D.
Organizational Affiliation
Quintiles, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quintiles, Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States

12. IPD Sharing Statement

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Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

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