Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

Revalesio

Status and phase

Completed

Phase 1

Conditions

Myocardial Infarct

Treatments

Drug: RNS60

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01264783

11.1.1.H1

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.