Status:
COMPLETED
Safety and Tolerability of RNS60 Given by IV to Healthy Subjects
Lead Sponsor:
Revalesio Corporation
Conditions:
Myocardial Infarct
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Males between 18-55 years
- Minimum body weight of 60 kg
- BMI of 18-32 kg/m2
- Able to execute informed written consent
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01264783
Start Date
July 1 2011
End Date
September 1 2011
Last Update
October 4 2011
Active Locations (1)
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1
Quintiles, Inc.
Overland Park, Kansas, United States, 66211