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.

Authors

Hironori Konishi, Takeyuki Shindo, Michio Yagi, Takashi Eto, Rie Yazawa, Makoto Yono, Naoki Cho, Hideki Fushimi, Jun Morita

Published in

Advances in therapy. Aug 14, 2026. Epub Aug 14, 2026.

Abstract

DMB-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.
Healthy 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_t) and maximum serum concentration (C_max).
This 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_t (n = 74/73) ranged from 0.826 to 1.011, which was contained within the prespecified bioequivalence range of 0.80 to 1.25. By contrast, the 90% CI for the geometric LSM ratio of C_max (n = 74/73) ranged from 0.762 to 0.984. The proportion of participants experiencing any adverse event (AE) was 37.3% (28 participants) in the DMB-3115 group and 48.0% (36 participants) in the Stelara group. The most common AE in the DMB-3115 group (n = 75) was blood creatine phosphokinase increased. All AEs were mild or moderate in severity. The proportions of participants with post-dose anti-drug antibodies and neutralizing antibodies were lower in the DMB-3115 group (n = 75).
Bioavailability of DMB-3115 was considered similar to that of Stelara in the Japanese population. DMB-3115 was well tolerated without any new safety concern.
Clinical Trial Registration Japan Registry of Clinical Trials (jRCT2071210135; registered March 22, 2022).

PMID:
42599579
Bibliographic data and abstract were imported from PubMed on 15 Aug 2026.

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