Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

Myocardial Infarct Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264783
• Other study ID #: 11.1.1.H1
• Status: Completed
• Phase: Phase 1
• First received: December 20, 2010
• Last updated: September 30, 2011
• Start date: July 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Revalesio Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Myocardial Infarct
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
United States	Quintiles, Inc.	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Revalesio Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability	Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.	6 days	Yes
Secondary	Biomarkers	Analysis of blood samples for various biomarkers	6 days	Yes