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A randomized, double-blind and parallel group study to compare the pharmacokinetic and safety of QL1203 and Vectibix® in healthy males.
This is a phase I,single center, randomized, double-blind,single-dose and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of of QL1203 or Vectibix® in healthy male volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of QL1203 or Vectibix® in healthy male volunteers".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1203 | Experimental | Participants only receive QL1203, 6mg/kg on Day 1. |
|
| Vectibix® | Active Comparator | Participants only received Vectibix®,6 mg/kg on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1203 | Drug | 6 mg/kg intravenous (IV) infusion 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. | 36 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunjiang Yu, CMO | Contact | 0531-83129659 | shunjiang.yu@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiwei Ouyang, Professor | Cancer Hospital of Guizhou Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guizhou Cancer Hospital | Recruiting | Guiyang | Guizhou | 550000 | China |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Vectibix® |
| Drug |
6 mg/kg intravenous (IV) infusion only once,on the first day. |
|
| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650032 | China |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |