At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 35 enrolled
Drug / intervention
RPH-104 +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, Single-center, Phase I, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating RPH-104 and Sodium chloride Sterile Injection 0.9% w/v for Healthy. Completed, enrolled 35 participants across 1 site.
Detailed Summary
The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesTurkey (Türkiye)
CollaboratorsMonitorCRO
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJan 2016
First PostedJan 2016
Primary CompletionJun 2017
TodayJul 2026
First PostedJan 29, 2016
Enrollment StartJan 1, 2016
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.4 years ago
Interventions
RPH-104biological
Anti-IL-1 Mab
Sodium chloride Sterile Injection 0.9% w/vother
Sterile saline solution