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

Boan Biotech

Status and phase

Completed

Phase 1

Conditions

Non Small Cell Lung Cancer Metastatic

Non Small Cell Lung Cancer Recurrent

Metastatic Colorectal Cancer

Treatments

Drug: LY01008

Drug: Avastin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05110118

LY01008/CT-CHN-103

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts 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