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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.
This is a phase I, single center, randomized, double-blind and parallel group clinical trial .
The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers.
The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile,observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20090 | Experimental | Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day |
|
| Xgeva® | Active Comparator | Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20090 | Drug | A human IgG2 monoclonal antibody with affinity and specificity for human RANKL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC0-t ) | 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 |
| Serum type 1 C-telopeptide(CTX1) |
| Measure | Description | Time Frame |
|---|---|---|
| Antidrug antibody(ADA): | percentage of subjects positive for antidrug antibody | 155days |
| Neutralizing antibody(Nab) | percentage of subjects positive for Nab |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36112084 | Derived | Lin Y, Yang H, Yang X, Guo C, Yang S, Yang G, Wu Q, Pan C, Sun C, Li C, He L, Huang J, Pei Q. Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study. Expert Opin Investig Drugs. 2022 Oct;31(10):1125-1132. doi: 10.1080/13543784.2022.2123737. Epub 2022 Sep 16. |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Xgeva® |
| Drug |
A human IgG2 monoclonal antibody with affinity and specificity for human RANKL |
|
explore the pharmacodynamic profile by detecting the serum concentration of CTX1
| 155days |
| 155days |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |