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ABSTRACT
Objective
HS-20090 is a proposed biosimilar candidate of Denosumab (Xgeva®). The study aimed to evaluate the similarity of pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity between HS-20090 and Xgeva® in healthy Chinese subjects.
Methods
A single-center, randomized, double-blinded, active-controlled study was conducted in healthy Chinese adult male subjects. A total of 154 subjects were planned to be randomly assigned (1:1) to receive 120 mg of either HS-20090 or Xgeva® in a single subcutaneous injection, with a follow-up period of 155 days. The primary objective was to evaluate the bioequivalence of PK. The primary endpoints were Cmax and AUC0-∞. The secondary objectives were to evaluate the similarity of PD, safety, and immunogenicity.
Results
All 154 subjects were included in the PK, PD, and safety analyses. The 90% CIs of GMRs of HS-20090/Xgeva® for Cmax, AUC0-t, and AUC0-∞ were 90.49 ~ 100.23%, 94.45 ~ 104.61%, and 94.08 ~ 105.23%, respectively, achieving the bioequivalence criteria of 80 ~ 125%. The PD parameters and incidence of adverse events between HS-20090 and denosumab were also similar, with no detection of ADA in both the groups.
Conclusion
HS-20090 was highly similar to Xgeva®, with regard to PK, PD, safety profiles, and immunogenicity in healthy Chinese subjects. These data support subsequently comparative clinical study for bone metastases in solid tumors.
Clinical trial registration
www.clinicaltrials.gov identifier is NCT04494373.
Acknowledgments
The authors thank the subjects who participated in this clinical trial, study coordinators, and support staff.
Declaration of interest
The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
Guoping Yang, Jie Huang, and Qi Pei conceived and designed the clinical trial. Xiaoyan Yang, Can Guo, and Shuang Yang conducted the clinical trial. Yaqi Lin and Heng Yang wrote initial draft of the manuscript. Jie Huang and Qi Pei identified papers for inclusion. Qiong Wu, Chao Pan, Changan Sun, Chuan Li, and Liangliang He checked all the data and did language polishing. All authors contributed to analysis and interpretation of results and agreed upon the final version of the manuscript.