2. Academic Validation
  3. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Gerilimzumab (GB224), a recombinant humanized interleukin-6 monoclonal antibody, in healthy Chinese adults: A randomized controlled dose-escalation study

Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of Gerilimzumab (GB224), a recombinant humanized interleukin-6 monoclonal antibody, in healthy Chinese adults: A randomized controlled dose-escalation study

  • Expert Opin Investig Drugs. 2023 Feb;32(2):161-170. doi: 10.1080/13543784.2023.2178894.
Diqin Yan 1 2,  Suping Niu 1,  Dingyuan Hu 1 2,  Wenliang Dong 1 2,  Yunjuan Sun 3,  Qian Wang 1,  Simin Wang 1 4,  Qun Gu 1,  Gang Liu 5,  Jiaxue Wang 6,  Liming Chen 1,  Jie Lv 7,  Qingshan Zheng 8,  Haifeng Song 9,  Yi Fang 1
Affiliations

Affiliations

  • 1 Clinical Trial Institution, Peking University People's Hospital, Beijing, China.
  • 2 Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China.
  • 3 Beijing United-Power Pharma Tech Co., Ltd, Beijing, China.
  • 4 Department of Clinical Pharmacy, Xuzhou Medical University, Xuzhou, China.
  • 5 Department of Pharmacy, Peking University People's Hospital, Beijing, China.
  • 6 Department of Pharmacy, Guizhou Provincial People's Hospital, Guiyang, China.
  • 7 Department of Intensive Care Units, Peking University People's Hospital, Beijing, China.
  • 8 The Center for Drug Clinical Research of Shanghai University of TCM, Shanghai, China.
  • 9 State Key Laboratory of Proteomics, Beijing Proteome Research Center, National Center for Protein Sciences (Beijing), Beijing Institute of Lifeomics, Beijing, China.
PMID: 36755413 DOI: 10.1080/13543784.2023.2178894
Abstract

Objectives: This study aimed to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of Gerilimzumab (GB224), a recombinant humanized IgG1λ monoclonal antibody against interleukin-6, in healthy Chinese adults.

Methods: Fifty-eight subjects were randomly assigned to receive a single subcutaneous dose of 2, 5, 10, 15, 20, 30 mg GB224 or placebo. Safety assessments were performed, and blood samples were collected for PK, PD, and immunogenicity analyses during a follow-up of 112 days.

Results: The most frequent adverse event was decreased fibrinogen (43.1%). GB224 was absorbed relatively fast with a median Tmax of 48 h (24-168 h) but eliminated slowly with a long mean half-life (839.38-981.63 h). Dose proportionality was shown to be in the dose range of 10-30 mg. A dose-dependent increase in serum interleukin-6 concentration from baseline was observed in the subjects receiving GB224. Only two subjects tested positive for antidrug antibodies after administration of GB224.

Conclusion: GB224 had a well-tolerated safety profile, desirable PK, and a low immunogenicity following a single-dose subcutaneous administration in healthy Chinese subjects. These findings warrant further investigation.

Keywords

IL-6; Pharmacokinetics; interleukin-6; pharmacodynamics; phase I study; tocilizumab.

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