A Phase I, Randomized, Double-Blind, Parallel-Group, Single-Dose Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of MSB11022, US-Reference Product, and EU-Reference Medicinal Product (Humira®) in Healthy Subjects
Phase of Trial: Phase I
Latest Information Update: 21 Feb 2017
At a glance
- Drugs Adalimumab (Primary)
- Indications Ankylosing spondylitis; Crohn's disease; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis
- Focus Pharmacokinetics
- Sponsors Merck KGaA
- 20 Jun 2016 New trial record
- 10 Jun 2016 Primary endpoint has been met. (AUC from time 0 to the last quantifiable concentration (AUC(0-last))), as per results published in the British Journal of Clinical Pharmacology.
- 10 Jun 2016 Primary endpoint has been met. (Maximum observed concentration Cmax), as per results published in the British Journal of Clinical Pharmacology.