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
About this trial
This is an interventional treatment trial for Myocardial Infarct
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.
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
NCT ID
NCT01264783
First Posted
December 20, 2010
Last Updated
September 30, 2011
Sponsor
Revalesio Corporation
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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