The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety
Latest Information Update: 10 Jan 2023
At a glance
- Drugs Infliximab biobetter (Primary) ; Infliximab
- Indications Ankylosing spondylitis; Crohn's disease; Psoriasis; Rheumatoid arthritis; Ulcerative colitis
- Focus Pharmacokinetics
- Sponsors Taizhou Mabtech Pharmaceuticals
- 06 Jan 2023 Results assessing the pharmacokinetic characteristics of CMAB008 and Remicade in healthy subjects and patients with moderately to severely active rheumatoid arthritis (RA) were investigated using a population modeling approach, and the pharmacokinetic similarity of CMAB008 to Remicade from NCT04779892, NCT03478111trials, published in the Advances in Therapy.
- 01 Sep 2022 Primary endpoint has been met. (Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours After the Single Infusion of CMAB008/Remicade), as per Results published in the Clinical Pharmacology in Drug Development
- 01 Sep 2022 Results published in the Clinical Pharmacology in Drug Development