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A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 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 and subcutaneous injections of MW032 and Xgeva® in healthy volunteers.
The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers.
At the same time, preliminary evaluate the pharmacodynamic similarity between MW032 and Xgeva®.
Subjects would receive a single 120mg(1.7mL)of MW032 or Xgeva® through subcutaneous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MW032 | Experimental | MW032 injection (120mg) by subcutaneous injection once on the first day of treatment. |
|
| Xgeva® | Active Comparator | Xgeva® injection (120mg) by subcutaneous injection once on the first day of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MW032 | Drug | Subjects would receive a single 120mg (1.7 mL) of MW032 through subcutaneous injection, on the first day of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC0-t ) | Day0-Day161 | |
| Maximum serum concentration (Cmax) | Day0-Day161 |
| 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. | Day0-Day161 |
| serum CTX1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUCare Luzhong Hospital | Zibo | Shandong | 255400 | China |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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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 | Subjects would receive a single 120mg (1.7 mL) of Xgeva® through subcutaneous injection, on the first day of treatment. |
|
CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.
| Day0-Day161 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |