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The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL1101 with EU-Avastin® in healthy male volunteers.
Participants will receive a single injection of QL1101/ EU-Avastin®.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the 2 groups.
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 injections of QL1101 or EU-Avastin® in healthy volunteers.
The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers.
Subjects would receive a single 100mg(4ml) of QL1101or EU-Avastin® injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1101 | Experimental | QL1101, intravenous infusion 90 min (±5min), D1 (Day 1, single dose) |
|
| Avastin® | Active Comparator | Avastin®, intravenous infusion 90 min (±5min), D1 (Day 1, single dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1101 | Drug | 3mg/kg, single intravenous infusion over 90 min (± 5 min) on first day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ | To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single intravenous infusion in healthy volunteers | 99 day |
| Cmax | To evaluate pharmacokinetic similarity between QL1101 and Avastin® after a single | 99 day |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | To evaluate pharmacokinetic similarity between QL1101 and Avastin® | 99 day |
| Tmax | To evaluate pharmacokinetic similarity between QL1101 and Avastin® |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Avastin® |
| Drug |
3mg/kg, single intravenous infusion over 90 min (± 5 min) on first day |
|
| 99 day |
| t1/2 | To evaluate pharmacokinetic similarity between QL1101 and Avastin® | 99 day |
| CL | To evaluate pharmacokinetic similarity between QL1101 and Avastin® | 99 day |
| Vd | To evaluate pharmacokinetic similarity between QL1101 and Avastin® | 99 day |
| (AUC0--∞ -AUC0-t)/(AUC0--∞×100%) | To evaluate pharmacokinetic similarity between QL1101 and Avastin® | 99 day |
| the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0 | Safety, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.after a single intravenous infusion in healthy volunteers; | 99 day |
| immunogenicity | Immunogenicity will be assessed by the incidence of ADA and Nab. | 99 day |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |