Safety and Tolerability of RNS60 Given by IV to Healthy S... | NCT01264783

Studies
Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

NCT01264783

Sponsor

Revalesio Corporation

Status

Completed

Last Update Posted

Oct 4, 2011Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Myocardial Infarct

Interventions

RNS60
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Dec 20, 2010

First Submission Date that Met QC Criteria

Dec 21, 2010

First Posted Date

Dec 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2011

Last Update Posted Date

Oct 4, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
RNS60	Experimental	RNS60	Drug: RNS60
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
RNS60	Drug	RNS60 for intravenous administration	RNS60
Placebo

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

Measure	Description	Time Frame
Biomarkers	Analysis of blood samples for various biomarkers	6 days

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases