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

October 27, 2021 updated by: Shandong Boan Biotechnology Co., Ltd

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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）
Time Frame: From baseline to Day 99
From baseline to Day 99
Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞）
Time Frame: From baseline to Day 99
From baseline to Day 99
Maximum (peak) plasma concentration（Cmax）
Time Frame: From baseline to Day 99
From baseline to Day 99
Chloride（CL）
Time Frame: From baseline to Day 99
From baseline to Day 99
Terminal elimination half-life（t1/2）
Time Frame: From baseline to Day 99
From baseline to Day 99
Apparent volume of distribution（Vd）
Time Frame: From baseline to Day 99
From baseline to Day 99

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events(AEs)
Time Frame: From baseline to Day 99
From baseline to Day 99
Vital signs
Time Frame: From baseline to Day 99
From baseline to Day 99
Physical examinations
Time Frame: From baseline to Day 99
From baseline to Day 99
Clinical laboratory tests
Time Frame: From baseline to Day 99
From baseline to Day 99
12-lead ECGs
Time Frame: From baseline to Day 99
From baseline to Day 99
Positive rate of serum anti-drug antibody (ADA)
Time Frame: From baseline to Day 99
From baseline to Day 99
Positive rate of neutralizing antibody (NAb)
Time Frame: From baseline to Day 99
From baseline to Day 99

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Boan Biotechnology Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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