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The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety and immunogenicity profiles of QL2109 and Darzalex following a single intravenous infusion in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL2109 | Experimental |
| |
| Darzalex | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL2109 | Drug | Recombinant anti-CD38 fully human monoclonal antibody. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ | Area under the serum concentration-time curve from time 0 to infinity | Up to Day 71 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huan Zhou, Ph.D. | Contact | 13665527160 | zhouhuanbest@vip.163.com |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
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| Darzalex |
| Drug |
Daratumumab injection |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |