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

Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110118
• Other study ID #: LY01008/CT-CHN-103
• Status: Completed
• Phase: Phase 1
• Start date: August 4, 2020
• Est. completion date: January 13, 2021

Study information

• Verified date: October 2021
• Source: Shandong Boan Biotechnology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Colorectal Cancer
• Non Small Cell Lung Cancer Metastatic
• Non Small Cell Lung Cancer Recurrent

Intervention

Drug:
• LY01008
Single intravenous injection
• Avastin
Single intravenous injection

Locations

Country	Name	City	State
China	The Second Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Boan Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve from time zero to the last measurable concentration(AUC0-t)		From baseline to Day 99
Primary	Area under the plasma concentration-time curve from time zero to infinity(AUC0-8)		From baseline to Day 99
Primary	Maximum (peak) plasma concentration(Cmax)		From baseline to Day 99
Primary	Chloride(CL)		From baseline to Day 99
Primary	Terminal elimination half-life(t1/2)		From baseline to Day 99
Primary	Apparent volume of distribution(Vd)		From baseline to Day 99
Secondary	Adverse Events(AEs)		From baseline to Day 99
Secondary	Vital signs		From baseline to Day 99
Secondary	Physical examinations		From baseline to Day 99
Secondary	Clinical laboratory tests		From baseline to Day 99
Secondary	12-lead ECGs		From baseline to Day 99
Secondary	Positive rate of serum anti-drug antibody (ADA)		From baseline to Day 99
Secondary	Positive rate of neutralizing antibody (NAb)		From baseline to Day 99