Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

Sponsor

Revalesio Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01264783

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarct	Drug: RNS60 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RNS60 RNS60	Drug: RNS60 RNS60 for intravenous administration
Placebo Comparator: Placebo Placebo	Drug: Placebo 0.9% normal saline for injection

Arm

Intervention/Treatment

Experimental: RNS60

RNS60

Drug: RNS60

RNS60 for intravenous administration

Placebo Comparator: Placebo

Placebo

Drug: Placebo

0.9% normal saline for injection

Outcome Measures

Primary Outcome Measures

Tolerability [6 days]
Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.

Secondary Outcome Measures

Biomarkers [6 days]
Analysis of blood samples for various biomarkers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quintiles, Inc.	Overland Park	Kansas	United States	66211

Sponsors and Collaborators

Revalesio Corporation

Investigators

Principal Investigator: Kelly Craven, M.D., Quintiles, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Revalesio Corporation

ClinicalTrials.gov Identifier:

NCT01264783

Other Study ID Numbers:

11.1.1.H1

First Posted:

Dec 22, 2010

Last Update Posted:

Oct 4, 2011

Last Verified:

Sep 1, 2011

Additional relevant MeSH terms:

Myocardial Infarction

RNS60

Study Results

No Results Posted as of Oct 4, 2011