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MSB11022 in Healthy Subjects

NCT03014947 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2019-07-01

No results posted yet for this study

Summary

This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal Product (RMP) (Humira®) in healthy subjects.

Conditions

  • Healthy Subjects

Interventions

DRUG

MSB11022

Subjects will receive single dose of 40 milligram (mg) MSB11022 as a subcutaneous injection in the lower abdomen on Day 1.

DRUG

US-licensed Humira

Subject will receive single dose of 40 mg US-licensed Humira as a subcutaneous injection in the lower abdomen on Day 1.

DRUG

EU-approved Humira

Subject will receive single dose of 40 mg EU-approved Humira as a subcutaneous injection in the lower abdomen on Day 1.

Sponsors & Collaborators

  • Fresenius Kabi SwissBioSim GmbH

    lead INDUSTRY

Principal Investigators

  • Medical Responsible

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

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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 NCT03014947 on ClinicalTrials.gov