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Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS

NCT04018599 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2020-03-25

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection of 40 mg.

Conditions

Interventions

DRUG

40 mg MSB11022

Single dose, as a solution, administered subcutaneously, using an auto-injector.

DRUG

40 mg MSB11022

Single dose, as a solution, administered subcutaneously, using a pre-filled syringe.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Fresenius Kabi SwissBioSim GmbH

    lead INDUSTRY

Principal Investigators

  • Radmila Kanceva, MD, PhD · Fresenius Kabi SwissBioSim GmbH

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2020-03-17
Completion
2020-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04018599 on ClinicalTrials.gov