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Safety and Tolerability of RNS60 Given by IV to Healthy Subjects

NCT01264783 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-10-04

No results posted yet for this study

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

Interventions

DRUG

RNS60

RNS60 for intravenous administration

DRUG

Placebo

0.9% normal saline for injection

Sponsors & Collaborators

  • Revalesio Corporation

    lead INDUSTRY

Principal Investigators

  • Kelly Craven, M.D. · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01264783 on ClinicalTrials.gov