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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer; Non Small Cell Lung Cancer Metastatic; Non Small Cell Lung Cancer Recurrent
• Intervention / Treatment: Drug: LY01008; Drug: Avastin

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shandong Boan Biotechnology Co., Ltd

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): January 13, 2021
• Study Completion (Actual): January 13, 2021

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Endothelial Growth Factors
• Other Study ID Numbers: LY01008/CT-CHN-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No