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

Shandong Boan Biotechnology Co., Ltd112 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

112

Conditions

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

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t）