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Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects

NCT02667639 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-12-28

Study results available
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Summary

The purpose of this first in human study is to evaluate the safety and tolerability of RPH-104 in humans.

Conditions

  • Healthy

Interventions

BIOLOGICAL

RPH-104

Anti-IL-1 Mab

OTHER

Sodium chloride Sterile Injection 0.9% w/v

Sterile saline solution

Sponsors & Collaborators

  • MonitorCRO

    collaborator INDUSTRY

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Sibel Goksel, MD, PhD · ARGEFAR

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT02667639 on ClinicalTrials.gov