LY06006

DRUG4 trials

Sponsors

Shandong Boan Biotechnology Co. Ltd., Shandong Boan Biotechnology Co. Ltd., Luye Pharma Group Ltd.

Conditions

Healthy AdultsPostmenopausal OsteoporosisPostmenopausal osteoporosis

Phase 1

A Study to Evaluate the Denosumab in Healthy Adults

Luye Pharma Group Ltd.Healthy Adults

Start: 2018-01-10End: 2019-12-28Target: 32Updated: 2018-02-09

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

Phase 3

A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture

Luye Pharma Group Ltd.Postmenopausal Osteoporosis

Start: 2019-06-30End: 2021-12-31Target: 448Updated: 2021-09-29

A randomized, double-blind, parallel-group, active-controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of LY06006 compared with EU-Prolia in postmenopausal women with osteoporosis

CompletedCTIS2024-513591-18-00

Shandong Boan Biotechnology Co. Ltd., Shandong Boan Biotechnology Co. Ltd.Postmenopausal osteoporosis

Start: 2023-04-26End: 2025-06-13Target: 460Updated: 2025-03-27

Related Papers

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