Prolia

BIOLOGICAL6 trials

Sponsors

Shanghai Hansoh Biomedical Co., Ltd, Luye Pharma Group Ltd., Alvotech Swiss AG, Enzene Biosciences Ltd., Amgen

Conditions

Healthy AdultsHealthy Male SubjectsHealthy VolunteersOsteoporosisPostmenopausal Osteoporosis

Phase 1

Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

Shanghai Hansoh Biomedical Co., LtdPostmenopausal Osteoporosis

Start: 2021-07-26End: 2022-06-30Target: 174Updated: 2021-08-25

A Study to Evaluate LY06006 and Prolia in Healthy Adults

Luye Pharma Group Ltd.Healthy Adults

Start: 2020-12-09End: 2021-12-31Updated: 2021-07-22

AVT03 With Prolia in Healthy Male Subjects

CompletedNCT05126784

Alvotech Swiss AGHealthy Male Subjects

Start: 2022-06-29End: 2023-10-16Updated: 2024-05-29

Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers

CompletedNCT06361355

Taizhou Mabtech Pharmaceutical Co.,LtdHealthy Volunteers

Start: 2023-11-02End: 2024-07-05Updated: 2024-11-07

Phase 3

A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®

CompletedNCT05405725

Enzene Biosciences Ltd.Postmenopausal Osteoporosis

Start: 2022-07-04End: 2024-07-18Updated: 2026-02-10

Phase 4

Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China

Active, not recruitingNCT06332014

AmgenOsteoporosis

Start: 2024-08-06End: 2027-01-23Updated: 2026-02-12

Related Papers

A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, pharmacodynamic, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (60 mg/mL) in healthy male adults

Expert Opinion on Investigational Drugs2025-05-131 citations

Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a biosimilar of denosumab (LY06006): a randomized, double-blind, single-dose, parallel-controlled clinical study in healthy Chinese subjects

Expert Opinion on Investigational Drugs2022-09-013 citations