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Clinical trial

A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects

NCT04018599 is registered in ClinicalTrials.gov with Fresenius Kabi SwissBioSim GmbH as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects
Lead sponsor
Fresenius Kabi SwissBioSim GmbH
Phase
Phase 1
Overall status
Completed
Start date
July 15, 2019
Completion date
March 17, 2020
Enrollment
216 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

ankylosing spondylitis, crohn disease, hidradenitis suppurativa, non-infectious uveitis, pediatric crohns disease, pediatric plaque psoriasis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis