Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial.

Guo, Yinhan; Guo, Tingting; Di, Yujing; Xu, Wenyu; Hu, Zhitian; Xiao, Yanfeng; Yu, Heze; Hou, Jie

Guo, Yinhan; Guo, Tingting; Di, Yujing; Xu, Wenyu; Hu, Zhitian; Xiao, Yanfeng; Yu, Heze; Hou, Jie.

Affiliation

Guo Y; Mabwell (Shanghai) Bioscience Co., Ltd, Shanghai, Jiangsu, China.
Guo T; Phase I Center, Peking University (PKU) Care, Luzhong Hospital, Zibo, Shandong, China.
Di Y; Phase I Center, Peking University (PKU) Care, Luzhong Hospital, Zibo, Shandong, China.
Xu W; Mabwell (Shanghai) Bioscience Co., Ltd, Shanghai, Jiangsu, China.
Hu Z; Mabwell (Shanghai) Bioscience Co., Ltd, Shanghai, Jiangsu, China.
Xiao Y; Mabwell (Shanghai) Bioscience Co., Ltd, Shanghai, Jiangsu, China.
Yu H; Mabwell (Shanghai) Bioscience Co., Ltd, Shanghai, Jiangsu, China.
Hou J; Phase I Center, Peking University (PKU) Care, Luzhong Hospital, Zibo, Shandong, China.

Expert Opin Biol Ther ; 23(8): 705-715, 2023.

Article in En | MEDLINE | ID: mdl-36892190

Subject(s)
Key words

Denosumab; MW031; equivalence; pharmacodynamics; pharmacokinetics; safety

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antibodies, Monoclonal, Humanized / Biosimilar Pharmaceuticals / Denosumab Type of study: Clinical_trials Limits: Humans / Male Language: En Journal: Expert Opin Biol Ther Journal subject: BIOLOGIA / TERAPEUTICA Year: 2023 Document type: Article Affiliation country: Country of publication:

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