Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Colorectal Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent

Intervention / Treatment
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* Drug: LY01008
* Drug: Avastin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers Subjects aged 18 - 45 years Subjects weighing ≥ 50.0 kg and ≤ 100.0 kg Subjects with a body mass index (BMI) ≥ 19.0 and ≤ 26.0 kg/m2 Exclusion Criteria: Subjects with evidence or history of clinically significant disease Subjects with a history of previous cancer Subjects with a history of hypertension, or abnormal blood pressure at screening/baseline measurements (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg confirmed by a repeat measurement on the same day) Subjects with a history of blood donation 3 months before study drug infusion Subjects with a history of exposure to antibodies 12 months before study drug infusion Subjects with previous exposure to anti-VEGF therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY01008<br>Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min). | Drug: LY01008<br>* Single intravenous injection<br>* Other names: Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection;|
| Active Comparator: Avastin<br>Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min). | Drug: Avastin<br>* Single intravenous injection<br>* Other names: Bevacizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events(AEs) |  | From baseline to Day 99 | 
| Vital signs |  | From baseline to Day 99 | 
| Physical examinations |  | 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 |