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Henlius Reports First Patients Dosing in P-I Study of HLX14 (denosumab- biosimilar)

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Henlius Reports First Patients Dosing in P-I Study of HLX14 (denosumab- biosimilar)

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  • The first patient has been dosed in a P-I study of HLX14- conducted in 2 parts- Part 1 is a pilot study assessing PK/PD- safety- tolerability & immunogenicity of HLX14 vs EU-sourced denosumab (SC) in healthy male volunteers
  • Part 2 is a four-arm study assessing the bioequivalence of HLX14 vs US-- EU-- CN-sourced denosumab. The study also evaluates PD- safety- tolerability- and immunogenicity between HLX14 and the reference drug
  • Results from the P-I study will provide reference for the dosing scheme in the clinical studies of HLX14

 ­ Ref: Henlius | Image: BioSpectrum Asia

Click here to­ read the full press release 

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