At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 33 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.
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Dose-Escalating Phase 1b Study to Evaluate the Safety, PK, PD and Immunogenicity of N-Rephasin® SAL200 After Continuous IV Infusion in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating N-Rephasin® SAL200 and INT200-Placebo for Healthy Volunteers and 3 related conditions. Completed, enrolled 33 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers, Anti-Bacterial Agents, Methicillin-Resistant Staphylococcus Aureus, Methicillin-Sensitive Staphylococcus Aureus Infection
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
Enrollment StartFeb 2018
First PostedFeb 2018
Primary CompletionFeb 2019
TodayJul 2026
First PostedFeb 26, 2018
Enrollment StartFeb 7, 2018
Primary CompletionFeb 7, 2019
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 8.3 years ago
Interventions
N-Rephasin® SAL200biological
continuous intravenous infusion over 60 minutes
INT200-Placeboother
Formulation buffer except active ingredient for continuous intravenous infusion over 60 minutes