MedTrace Logo

A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers

NCT03446053 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-11-03

Study results available
· View outcomes & findings →

Summary

To evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of N-Rephasin® SAL200 following single and multiple ascending doses in healthy male volunteers after continuous intravenous infusion over 60 minutes.

Conditions

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

Interventions

BIOLOGICAL

N-Rephasin® SAL200

continuous intravenous infusion over 60 minutes

OTHER

INT200-Placebo

Formulation buffer except active ingredient 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
2018-02-07
Primary Completion
2019-02-07
Completion
2019-02-07

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT03446053 on ClinicalTrials.gov