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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05110118
Other study ID # LY01008/CT-CHN-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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