Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a phase I, single center, randomized, single-blind and parallel group clinical trial .The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20090-2 | Experimental |
| |
| Prolia® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20090-2 | Drug | Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-infinity curve (AUC0-∞ ) | Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to infinite time. | 155days |
| Cmax | maximum concentration | 155days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events(AE) | The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment. | 155days |
| ADA |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Liu, PhD | Contact | 13507183749 | +86 | tjyxboffice@sinq.com |
| Xiuhua Ren, Master | Contact | 15902713190 | +86 | 271052026@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Liu, PhD | Huazhong University of Science and Technoogy | Principal Investigator |
| Xiuhua Ren, Master | Huazhong University of Science and Technoogy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huazhong University of Science and Technoogy | Recruiting | Wuhan | Hubei | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prolia |
| Drug |
Subcutaneously injection of Prolia® (60mg/1mL) once on the first day |
|
percentage of subjects positive for antidrug antibody
| 155days |
| Nab | percentage of subjects positive for Nab | 155days |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |