A Study Comparing Pharmacokinetics, Safety, Tolerability And Immunogenicity Of FKB327 A Biosimilar Of Adalimumab With European Union (EU)-Approved Humira And United States (US)- Licensed Humira After Single Subcutaneous Doses In Healthy Subjects.
Phase of Trial: Phase I
Latest Information Update: 08 Feb 2017
At a glance
- Drugs Adalimumab (Primary)
- Indications Rheumatoid arthritis
- Focus Adverse reactions; First in man; Pharmacokinetics
- 08 Feb 2017 New trial record
- 30 Jan 2017 Primary endpoint (Equivalence analysis of the geometric means of AUC0-t , AUC0-infinity and Cmax for FKB327, EU-Humira and US-Humira, and that EU-Humira and US-Humira) has been met, according results to published in the British Journal of Clinical Pharmacology.
- 30 Jan 2017 Results published in the British Journal of Clinical Pharmacology.