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A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers

NCT01855048 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-11-03

Study results available
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Summary

The Objectives of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of single dose of N-Rephasin® SAL200 in healthy male subjects.

Conditions

  • Healthy Volunteers
  • Anti-Bacterial Agents
  • Methicillin-Resistant Staphylococcus Aureus

Interventions

BIOLOGICAL

N-Rephasin® SAL200

continuous intravenous infusion over 60 minutes

OTHER

INT200-Placebo

Formulation buffer for continuous intravenous infusion over 60 minutes

Sponsors & Collaborators

  • Intron Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • In Jin Jang, M.D., Ph. D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-06
Primary Completion
2014-02-07
Completion
2014-02-07

Countries

  • South Korea

Study Locations

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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 NCT01855048 on ClinicalTrials.gov