Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

NCT ID: NCT01264783

Last Updated: 2011-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-09-30

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.

Conditions

Myocardial Infarct

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RNS60

RNS60

Group Type: EXPERIMENTAL

RNS60

Intervention Type: DRUG

RNS60 for intravenous administration

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% normal saline for injection

Interventions

RNS60

RNS60 for intravenous administration

Intervention Type: DRUG

Placebo

0.9% normal saline for injection

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Revalesio Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Craven, M.D.

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

Quintiles, Inc.

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

11.1.1.H1

Identifier Type: -

Identifier Source: org_study_id