Clinical trial NCT05110118: Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Colorectal Cancer
Non Small Cell Lung Cancer Metastatic
Non Small Cell Lung Cancer Recurrent
Lead sponsor: Shandong Boan Biotechnology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 112
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t）
timeFrame: From baseline to Day 99
measure: Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞）
timeFrame: From baseline to Day 99
measure: Maximum (peak) plasma concentration（Cmax）
timeFrame: From baseline to Day 99
measure: Chloride（CL）
timeFrame: From baseline to Day 99
measure: Terminal elimination half-life（t1/2）
timeFrame: From baseline to Day 99
measure: Apparent volume of distribution（Vd）
timeFrame: From baseline to Day 99
Secondary outcomes:
measure: Adverse Events(AEs)
timeFrame: From baseline to Day 99
measure: Vital signs
timeFrame: From baseline to Day 99
measure: Physical examinations
timeFrame: From baseline to Day 99
measure: Clinical laboratory tests
timeFrame: From baseline to Day 99
measure: 12-lead ECGs
timeFrame: From baseline to Day 99
measure: Positive rate of serum anti-drug antibody (ADA)
timeFrame: From baseline to Day 99
measure: Positive rate of neutralizing antibody (NAb)
timeFrame: From baseline to Day 99
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
Study officials:
References:
citation: 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.