Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects
Phase 1
Completed
- Conditions
- Non Small Cell Lung Cancer MetastaticNon Small Cell Lung Cancer RecurrentMetastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT05110118
- Lead Sponsor
- Shandong Boan Biotechnology Co., Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 112
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Avastin Avastin Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min). LY01008 LY01008 Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min).
- Primary Outcome Measures
Name Time Method Terminal elimination half-life（t1/2） From baseline to Day 99 Apparent volume of distribution（Vd） From baseline to Day 99 Maximum (peak) plasma concentration（Cmax） From baseline to Day 99 Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞） From baseline to Day 99 Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t） From baseline to Day 99 Chloride（CL） From baseline to Day 99
- Secondary Outcome Measures
Name Time Method Vital signs From baseline to Day 99 Clinical laboratory tests From baseline to Day 99 Positive rate of neutralizing antibody (NAb) From baseline to Day 99 Adverse Events(AEs) From baseline to Day 99 Physical examinations From baseline to Day 99 12-lead ECGs From baseline to Day 99 Positive rate of serum anti-drug antibody (ADA) From baseline to Day 99
Trial Locations
- Locations (1)
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China