Metastatic Colorectal Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
Conditions
Brief summary
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.
Interventions
DRUGLY01008
Single intravenous injection
DRUGAvastin
Single intravenous injection
Sponsors
Shandong Boan Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Adverse Events(AEs) | From baseline to Day 99 |
| Positive rate of neutralizing antibody (NAb) | 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 |
Countries
China
Outcome results
None listed