Clinical trials: Denosumab
- Drug or intervention Denosumab
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Healthy
A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection
This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics…
- Trial name
- NCT06095427
- Testing
- LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia
- Where
- 2 sites in Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Shandong Boan Biotechnology Co., Ltd
This is a Phase I Study Conducted in Healthy Volunteers
AVT03 With Xgeva in Healthy Male Subjects
This study has been designed as a randomized, double-blind, parallel-group study and in healthy adult male subjects of age 28 years to 55 years old.
- Trial name
- NCT05876949
- Testing
- AVT03, Denosumab
- Where
- 3 sites in Poland, South Africa and 1 more
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Healthy Volunteers
A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva
Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects.
- Trial name
- NCT05299073
- Testing
- MB09, US-sourced Xgeva, EU-sourced Xgeva
- Where
- Poland
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- mAbxience Research S.L.
Healthy Volunteers
Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers
This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807…
- Trial name
- NCT06361355
- Testing
- Post-change CMAB807, Prolia
- Where
- China
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Healthy Male Subjects
AVT03 With Prolia in Healthy Male Subjects
This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old.
- Trial name
- NCT05126784
- Testing
- AVT03, Prolia
- Where
- 4 sites in Australia, New Zealand and 1 more
- Volunteers
- 209 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Healthy Volunteers
Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS
This study is to compare the Pharmacokinetics, Pharmacodynamics, safety, and tolerability of Bmab 1000 and Prolia® in normal healthy volunteers.
- Trial name
- DENARIUS (NCT05323708)
- Testing
- Bmab 1000, Prolia®
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Biocon Biologics UK Ltd
Healthy Volunteers
Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers
This is a randomized, double-blinded, controlled Phase I three-arms study of CMAB807X administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of…
- Trial name
- NCT05808673
- Testing
- Post-change CMAB807X, Pre-change CMAB807X, Xgeva®
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Healthy
Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
A Dual-center , Randomized, double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults
- Trial name
- NCT05777109
- Testing
- HS-20090, Xgeva®
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy
Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects
This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.
- Trial name
- NCT04621318
- Testing
- Denosumab
- Where
- 2 sites in United States, France
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Samsung Bioepis Co., Ltd.
Postmenopausal Osteoporosis
Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults
A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.
- Trial name
- NCT04940845
- Testing
- HS-20090-2, Prolia
- Where
- China
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Shanghai Hansoh Biomedical Co., Ltd
Healthy Adults
A Study to Evaluate LY06006 and Prolia in Healthy Adults
A randomized, double-blind, parallel-group study in Chinese healthy male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection
- Trial name
- NCT04973722
- Testing
- LY06006, Prolia
- Where
- China
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Osteoporosis, Postmenopausal
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.
- Trial name
- MW031 (NCT04798313)
- Testing
- MW031, Prolia®
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Bone Tumor
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 and Xgeva® in healthy adults.
- Trial name
- MW032 (NCT04798326)
- Testing
- MW032, Xgeva®
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Healthy
Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
- Trial name
- NCT04673799
- Testing
- MV088 injection, Prolia® injection
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Kunming Pharmaceuticals, Inc.
Postmenopausal Osteoporosis
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of…
- Trial name
- NCT03925051
- Testing
- Prolia®, CMAB807
- Where
- China
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Shanghai Biomabs Pharmaceutical Co., Ltd.
Bone Metastasis From Solid Tumors
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy adults.
- Trial name
- NCT04494373
- Testing
- HS-20090, Xgeva®
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy People
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Prolia® in healthy adults
- Trial name
- NCT04213105
- Testing
- QL1206, Prolia®
- Where
- China
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy Adults
A Study to Evaluate LY01011 and Xgeva® in Healthy Adults
A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults
- Trial name
- NCT04198636
- Testing
- LY01011, Xgeva 120 MG in 1.7 ML Injection
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy People
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Xgeva® in healthy adults.
- Trial name
- NCT03651947
- Testing
- QL1206, Xgeva®
- Where
- China
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy Volunteer
Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product
To evaluate the bioequivalence based on pharmacokinetics (PK) of a single 120 mg subcutaneous dose of denosumab administered to healthy volunteers using denosumab CP4 or denosumab CP2 drug products.
- Trial name
- NCT02053753
- Testing
- Denosumab CP4, Denosumab CP2
- Where
- 2 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Amgen