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This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY01008 | Experimental | Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min). |
|
| Avastin | Active Comparator | Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY01008 | Drug | Single intravenous injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t） | From baseline to Day 99 | |
| Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞） | From baseline to Day 99 | |
| Maximum (peak) plasma concentration（Cmax） | From baseline to Day 99 | |
| Chloride（CL） | From baseline to Day 99 | |
| Terminal elimination half-life（t1/2） | From baseline to Day 99 | |
| Apparent volume of distribution（Vd） | From baseline to Day 99 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events(AEs) | From baseline to Day 99 | |
| Vital signs | From baseline to Day 99 | |
| Physical examinations |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34913787 | Derived | Zhou R, Yang J, Liu Y, Zhang Q, Lu C, Tang K, Li X, Tang W, Gao E, Wu C, Dou C, Hu W. A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin(R) in healthy Chinese male subjects. Expert Opin Biol Ther. 2022 Feb;22(2):263-269. doi: 10.1080/14712598.2022.2019703. Epub 2021 Dec 27. |
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| Avastin | Drug | Single intravenous injection |
|
|
| From baseline to Day 99 |
| Clinical laboratory tests | From baseline to Day 99 |
| 12-lead ECGs | From baseline to Day 99 |
| Positive rate of serum anti-drug antibody (ADA) | From baseline to Day 99 |
| Positive rate of neutralizing antibody (NAb) | From baseline to Day 99 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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