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Pharmacokinetics/Pharmacodynamics (PK/PD) Equivalence Study of MSB11456

NCT03282851 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 696

Last updated 2020-02-12

No results posted yet for this study

Summary

This study aims to compare the PK/PD of a single injection of investigational Medicinal Product (IMP) MSB11456, US licensed Actemra and EU approved RoActemra in healthy adult subjects.

Conditions

  • Healthy

Interventions

DRUG

MSB11456

Subjects will receive a single injection of MSB11456 on Day 1.

DRUG

US-licensed Actemra

Subjects will receive a single injection of US-licensed actemra on Day 1.

DRUG

EU-approved RoActemra

Subjects will receive a single injection of EU-approved RoActemra on Day 1.

Sponsors & Collaborators

  • Fresenius Kabi SwissBioSim GmbH

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Fresenius Kabi SwissBioSim GmbH

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2019-10-01
Completion
2019-10-01
FDA Drug
Yes

Countries

  • New Zealand

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 NCT03282851 on ClinicalTrials.gov