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Pharmacodynamics and Pharmacokinetics of AMG 531, a Thrombopoiesis-Stimulating Peptibody, in Healthy Japanese Subjects: A Randomized, Placebo-Controlled Study

From the Clinical Investigation Center, Kitasato University East Hospital, Kanagawa, Japan (Y. Kumagai, T. Fujita, M. Ozaki, K. Sahashi); Amgen Limited, Tokyo, Japan (M. Ohkura, T. Ohtsu, Y. Arai, Y. Sonehara); and Amgen, Thousand Oaks, California (J. L. Nichol).

AMG 531 is a novel thrombopoiesis-stimulating peptibody being investigated for the treatment of chronic immune thrombocytopenic purpura. This double-blind, phase I study evaluated the safety, pharmacodynamics, and pharmacokinetics of AMG 531 in healthy Japanese men. Thirty subjects were randomly assigned 4:1 (AMG 531/placebo) to receive 1 dose of AMG 531 (0.3, 1, or 2 µg/kg) or placebo by subcutaneous injection; subjects were evaluated for 6 weeks. AMG 531 was generally well tolerated, with adverse events similar to placebo. Treatment-related adverse events (headache, "feeling hot," malaise) were reported for 5 of 24 AMG 531-treated subjects. Platelets generated after exposure to AMG 531 functioned normally. Four of 8 subjects receiving 1 µg/kg and 7 of 8 receiving 2 µg/kg had platelet count increases 1.5-fold over baseline, an effect similar to that seen in non-Japanese subjects. Serum AMG 531 concentrations were below the lower limit of quantification in all but 2 subjects receiving 2 µg/kg.

Key Words: Thrombopoiesis • thrombopoietin • immune thrombocytopenic purpura • platelets • platelet aggregation • AMG 531

Address for correspondence: Dr Yuji Kumagai, Kitasato University East Hospital, 2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan 228-8520.

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