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A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 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 QL1206 or Xgeva® in healthy volunteers.
The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of QL1206 or Xgeva® in healthy volunteers.
Meanwhile,observing the pharmacodynamic similarities of QL1206 or Xgeva® preliminarily.
Subjects would receive a single 120mg(1.7ml) of QL1206 or through subcutaneous injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1206 | Experimental | QL1206 injection (120mg) by subcutaneous injection once on the first day. |
|
| Xgeva® | Active Comparator | Xgeva® injection (120mg) by subcutaneous injection once on the first day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1206 | Drug | subcutaneous injection of 120 mg (1.7 ml)only once,on the first day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC0-t ) | Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to the last measurable concentration acquisition time t. | 134 day |
| 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. | 134 day |
| serum CTX1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| yanhua DING, Professor | The First Affiliated Hospital of Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| C000729682 | QL1206 |
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Xgeva® |
| Drug |
subcutaneous injection of 120 mg (1.7 ml)only once,on the first day. |
|
|
CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.
| 134 day |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |