CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
N-Rephasin® SAL200 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01855048
NCT01855048Phase 1Completed
CompareCT.gov

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

Intron Biotechnology, Inc.·interventional·Posted May 16, 2013·Updated Nov 3, 2021

In Brief

A Phase 1 clinical trial evaluating N-Rephasin® SAL200 and INT200-Placebo for Healthy Volunteers and 2 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus
CountriesSouth Korea
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 16, 2013
Enrollment StartAug 6, 2013
Primary CompletionFeb 7, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.1 years ago

Interventions

N-Rephasin® SAL200biological

continuous intravenous infusion over 60 minutes

INT200-Placeboother

Formulation buffer for continuous intravenous infusion over 60 minutes