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Open access Aug 2026

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.

INTRODUCTION 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. METHODS Healthy Japanese male participants aged 18 to 55 years were randomly...

Hironori Konishi, Takeyuki Shindo, Michio Yagi et al. · 0 citations
Open access Sep 2026

A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of sipavibart in healthy Japanese adults.

BACKGROUND Sipavibart, a recombinant human immunoglobulin G1-based monoclonal antibody against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, is approved in Japan for prevention of COVID-19 in immunocompromised individuals. This phase 1 study evaluated the safety and pharmacokinetics (PK) o...

Hiroshi Okada, T. Shinbo, Hyosung Kim et al. · 0 citations

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