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

Tracking Information

First Received Date ^ICMJE

December 20, 2010

Last Updated Date

September 30, 2011

Start Date ^ICMJE

July 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Tolerability [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01264783 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Biomarkers [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Analysis of blood samples for various biomarkers

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Infarct

Intervention ^ICMJE

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

Study Arm (s)

Experimental: RNS60
RNS60

Intervention: Drug: RNS60
Placebo Comparator: Placebo
Placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01264783

Other Study ID Numbers ^ICMJE

11.1.1.H1

Has Data Monitoring Committee

Responsible Party

Revalesio Corporation

Study Sponsor ^ICMJE

Revalesio Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kelly Craven, M.D.

Quintiles

Information Provided By

Revalesio Corporation

Verification Date

September 2011

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

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