Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

NCT01264783 | Completed Phase 1

• 1 other identifier: 11.1.1.H1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Tolerability

  Safety and tolerability of RNS60 administered by IV infusion to healthy volunteers.

  6 days

Secondary Outcomes (1)

• Biomarkers

  6 days

Study Arms (2)

RNS60

EXPERIMENTAL

RNS60

Drug: RNS60

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

RNS60 DRUG

RNS60 for intravenous administration

RNS60

Placebo DRUG

0.9% normal saline for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males between 18-55 years
• Minimum body weight of 60 kg
• BMI of 18-32 kg/m2
• Able to execute informed written consent

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Revalesio Corporation: lead

Study Sites (1)

Quintiles, Inc.

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

RNS60

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Kelly Craven, M.D.

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 22, 2010
• Study Start: July 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 4, 2011

Record last verified: 2011-09

Locations

US (1)