Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study
Creators: name: Yu, Kyung-Sang
name: Ryu, Hyunwook
name: Shin, Dongseong
name: Park, MinKyu
name: Hwang, JunGi
name: Moon, Seol Ju
name: Kim, Min-Gul
name: Keystone, Edward
name: Smolen, Josef S
name: Kim, SungHyun
name: Bae, YunJu
name: Jeon, DaBee
name: Jang, JiYoung
name: Yang, GoEun
name: Bae, JiHun
name: Lee, JaeYong
name: Burmester, Gerd R
Publisher: name: Taylor & Francis
Year: 2024
Subjects: subject: Space Science
subject: Medicine
subject: Pharmacology
subject: Environmental Sciences not elsewhere classified
subject: Chemical Sciences not elsewhere classified
subject: Immunology
subject: FOS: Clinical medicine
subject: Mental Health

description: This study compared the pharmacokinetics (PK), immunogenicity, and safety of candidate tocilizumab biosimilar, CT-P47, administered via auto-injector (CT-P47 AI) or pre-filled syringe (CT-P47 PFS), in healthy Asian adults. In this phase I, multicenter, open-label study, participants were randomized 1:1 to receive a single 162 mg/0.9 mL dose of CT-P47 via AI or PFS. Primary endpoints were area under the concentration – time curve from time zero to infinity (AUC<sub>0–inf</sub>) and maximum serum concentration (C<sub>max</sub>). PK equivalence was determined if 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were within the predefined 80–125% equivalence margin. Secondary PK parameters, immunogenicity, and safety outcomes were also assessed. Of 314 participants randomized (155 CT-P47 AI; 159 CT-P47 PFS), 310 received the study drug (153 CT-P47 AI; 157 CT-P47 PFS). Primary and secondary PK results, immunogenicity and safety were similar between groups. Ninety percent CIs for the ratio of gLSMs were within the predefined equivalence margin for AUC<sub>0–inf</sub> (85.87–102.94) and C<sub>max</sub> (82.98–98.16). PK equivalence between CT-P47 AI and CT-P47 PFS was demonstrated in healthy Asian adults, with comparable immunogenicity and safety between the two devices. ClinicalTrials.gov: NCT05617183. Tocilizumab is a biologic medicine used to treat inflammatory diseases, such as rheumatoid arthritis. A biosimilar is a drug that is an almost identical copy of an approved original (‘reference’) biologic medicine; it has identical efficacy and safety to the original medicine but is typically less expensive. CT‑P47 is in development as a possible tocilizumab biosimilar. Some patients prefer injections using an auto-injector (AI) rather than a pre-filled syringe (PFS), for reasons including ease of use and convenience. With an AI, medicine is delivered automatically by firmly pressing the device against the skin, whereas, with a PFS, a needle is inserted into the skin and medicine delivered by depressing the plunger. The injection of CT‑P47 using a PFS has shown comparable pharmacokinetics (i.e., the uptake, metabolism and excretion of the drug by the body) and safety to tocilizumab. Therefore, if the pharmacokinetics and safety of CT‑P47 administered via AI and PFS were shown to be similar, this might expand the choice of administration devices available to patients. In this study, 310 healthy adults received a single injection of CT‑P47 via AI or PFS. Blood samples were taken over 43 days to analyze pharmacokinetics. The uptake, metabolism and elimination of CT‑P47 by the body was similar when administered by each device, suggesting that CT‑P47 can be administered by either AI or PFS.