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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LY01008
Avastin
Sponsored by
Shandong Boan Biotechnology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Second Hospital of Anhui Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LY01008

Avastin

Arm Description

Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min).

Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min).

Outcomes

Primary Outcome Measures

Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t）
Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞）
Maximum (peak) plasma concentration（Cmax）
Chloride（CL）
Terminal elimination half-life（t1/2）
Apparent volume of distribution（Vd）

Secondary Outcome Measures

Adverse Events(AEs)
Vital signs
Physical examinations
Clinical laboratory tests
12-lead ECGs
Positive rate of serum anti-drug antibody (ADA)
Positive rate of neutralizing antibody (NAb)

Full Information

First Posted
October 25, 2021
Last Updated
October 27, 2021
Sponsor
Shandong Boan Biotechnology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05110118
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
January 13, 2021 (Actual)
Study Completion Date
January 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Boan Biotechnology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY01008
Arm Type
Experimental
Arm Description
Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min).
Arm Title
Avastin
Arm Type
Active Comparator
Arm Description
Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min).
Intervention Type
Drug
Intervention Name(s)
LY01008
Other Intervention Name(s)
Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection
Intervention Description
Single intravenous injection
Intervention Type
Drug
Intervention Name(s)
Avastin
Other Intervention Name(s)
Bevacizumab
Intervention Description
Single intravenous injection
Primary Outcome Measure Information:
Title
Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t）
Time Frame
From baseline to Day 99
Title
Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞）
Time Frame
From baseline to Day 99
Title
Maximum (peak) plasma concentration（Cmax）
Time Frame
From baseline to Day 99
Title
Chloride（CL）
Time Frame
From baseline to Day 99
Title
Terminal elimination half-life（t1/2）
Time Frame
From baseline to Day 99
Title
Apparent volume of distribution（Vd）
Time Frame
From baseline to Day 99
Secondary Outcome Measure Information:
Title
Adverse Events(AEs)
Time Frame
From baseline to Day 99
Title
Vital signs
Time Frame
From baseline to Day 99
Title
Physical examinations
Time Frame
From baseline to Day 99
Title
Clinical laboratory tests
Time Frame
From baseline to Day 99
Title
12-lead ECGs
Time Frame
From baseline to Day 99
Title
Positive rate of serum anti-drug antibody (ADA)
Time Frame
From baseline to Day 99
Title
Positive rate of neutralizing antibody (NAb)
Time Frame
From baseline to Day 99

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34913787
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.
Results Reference
derived

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

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