ArticleAdvances in therapy2026
Pharmacokinetics, Safety, and Immunogenicity of DMB-3115, a Ustekinumab Biosimilar for Immune-Mediated Diseases, in Healthy Japanese Male Participants: A Randomized, Double-Blind, Single-Dose Study.
Article in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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9 authors.
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Abstract
introductionDMB-3115 is a biosimilar to ustekinumab (Stelara®). We conducted a randomized controlled study to determine the similarity of bioavailability between DMB-3115 and Stelara (distributed in Japan) in healthy Japanese participants.
methodsHealthy Japanese male participants aged 18 to 55 years were randomly assigned in a 1:1 ratio to receive a single subcutaneous injection (45 mg) of DMB-3115 or Stelara. Participants were followed for 112 days. The primary pharmacokinetic (PK) endpoints were area under the concentration-time curve from time zero to the final sampling time point t (AUC
resultsThis study was conducted between April 11, 2022 and November 22, 2022. A total of 150 participants (75 in each group) received the study drug and were included in the safety analysis, whereas 147 participants (74 in the DMB-3115 group and 73 in the Stelara group) with properly measured PK data were included in the PK analysis. The 90% confidence interval (CI) for the geometric least squares mean (LSM) ratio (DMB-3115/Stelara) of AUC
conclusionBioavailability of DMB-3115 was considered similar to that of Stelara in the Japanese population. DMB-3115 was well tolerated without any new safety concern.
trial registrationClinical Trial Registration Japan Registry of Clinical Trials (jRCT2071210135; registered March 22, 2022).
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