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

• Status: Completed
• Trial end date: 2021-01-13
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shandong Boan Biotechnology Co., Ltd
• Treatments: Bevacizumab; Endothelial Growth Factors

Criteria

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