Samsung Bioepis announced the initiation of Phase 1 clinical trial for SB16, the company's proposed biosimilar referencing Prolia® (denosumab). The Phase 1 clinical trial for SB16 (denosumab) is a randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity between SB16 and Prolia® in healthy male volunteers.
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