2,, 3 When the ligand is bound to the OX40 receptor, which is expressed on activated T cells, the immune response may be enhanced by mechanisms described above. 1 The OX40 ligand is expressed on antigenвЂђpresenting cells (APCs) at the site of inflammation. OX40, a member of the tumor necrosis factor (TNF) receptor superfamily, suppresses apoptosis and induces late TвЂђcell proliferation, survival, and formation of memory TВ cells. It also indicated favorable pharmacological properties of the drug. Our study demonstrated the safety and tolerability of single and multiple administrations of KHK4083 in healthy Japanese and Caucasian subjects and Japanese patients with moderate to severe UC. Of 8 UC patients, a clinical response was observed in 3 patients (37.5%) and clinical remission in 2 patients (25.0%) in week 6. The PK profile of a single intravenous dose of 10 mg/kg KHK4083 was similar in healthy Japanese and Caucasian subjects. DrugвЂђrelated treatment emergent adverse events occurred in 21 healthy subjects (58.3%) and 5 patients with UC (62.5%) after administration of KHK4083. Also, we assessed the preliminary efficacy and pharmacodynamics of multiple intravenous doses in Japanese patients with moderate to severe ulcerative colitis (UC).

In this study, we aimed to assess the safety and tolerability of a single intravenous or subcutaneous administration of KHK4083 compared with placebo in healthy Japanese and Caucasian subjects and determined the pharmacokinetics (PK) and immunogenicity. Here, we report the results of the phase 1 study of KHK4083, a fully human antimonoclonal antibody specific for OX40. OX40 plays an essential role in maintaining late TвЂђcell proliferation and survival by suppressing apoptosis and by inducing TвЂђcell memory formation.

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