ABSTRACT
Background
MW031 is a biosimilar candidate of denosumab (Prolia®). This study aimed to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of MW031 to denosumab in healthy Chinese participants.
Research design and methods
In this single-center, randomized, double-blind, parallel-controlled, single-dose trial, participants were given 60 mg MW031 (N = 58) or denosumab (N = 61) by subcutaneous injection and observed for 140 days. The primary endpoint was the bioequivalence of PK parameters (Cmax, AUC0-∞), and secondary endpoints including PD parameter, safety, and immunogenicity.
Results
A comparison of main PK parameters showed that the geometric mean ratios (GMR) (90% confidence intervals [CIs]) of AUC0-∞ and Cmax for MW031 over denosumab were 105.48% (98.96%, 112.43%) and 98.58% (92.78%, 104.75%), respectively. The inter-CV values of AUC0-∞ and Cmax for MW031 ranged from 19.9% to 23.1%. PD parameter (sCTX) in the MW031 and denosumab groups were similar, and the positivity rates of immunogenicity were 0% in both groups. This study also showed similar safety profiles in both groups, and there were no drug-related, high-incidence and previously unreported adverse reactions.
Conclusion
This trial confirmed similar pharmacokinetic profiles of MW031 and denosumab in healthy male participants, and pharmacodynamic profile, immunogenicity and safety were comparable for both drugs.
Trial registration
NCT04798313; CTR20201149
Declaration of interest
Y Guo, W Xu, Z Hu, Y Xiao and H Yu are employees of Mabwell (Shanghai) Bioscience Co., Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Ethics
The protocol, amendments and other ethics committee review documents of this trial were assessed and approved by the Ethics Committee of Drug for Clinical Trials, Peking University (PKU) Care, Luzhong Hospital, Zibo. The trial was conducted according to the Declaration of Helsinki, the Good Clinical Practice for Drugs (GCP) issued by the National Medical Products Administration and other regulations[11]. All participants provided signed informed consent before study enrollment.
Author contributions
Study design, investigation and manuscript drafting: Y Guo and J Hou. Investigation: W Xu, Z Hu, Y Di, T Guo. Manuscript revision: Y Xiao and H Yu. Approval of the final manuscript: all authors.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14712598.2023.2178298