NCT01855048

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

A Randomized, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Safety, Pharmacokinetics and Phyarmacodynamcs of a Single Intravenous Dose of N-Rephasin® SAL200, in Healthy Male Valunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Intron Biotechnology, Inc. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The purposes of this study are to evaluate the pharmacokinetics, and pharmacodynamics and safety of an experimental intravenous medication, N-Rephasin® SAL200 in healthy male. Participants will include 36 male volunteers. Participants will be grouped according to dosage of N-Rephasin® SAL200 including placebo (0 mg/kg). Study procedures include: check of vital signs, reporting any experienced side effects, physical examination including assessment of the cardiovascular system, and blood sample collection for monitoring of pharmacokinetics, pharmacodynamics and antibody production etc. Participants will be involved in study related procedures for up to 50 days after injection.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	N-Rephasin® SAL200	continuous intravenous infusion over 60 minutes
OTHER	INT200-Placebo	Formulation buffer for continuous intravenous infusion over 60 minutes

Timeline

• Start date: 2013-08-06
• Primary completion: 2014-02-07
• Completion: 2014-02-07
• First posted: 2013-05-16
• Last updated: 2021-11-03
• Results posted: 2021-11-03

Locations

1 site across 1 country: South Korea