Clinical trial · Interventional
Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non Small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avastin | Drug | Bevacizumab | ALIAS |
| LY01008 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LY01008
- description
- Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min).
- interventionNames
- Drug: LY01008
- type
- ACTIVE_COMPARATOR
- label
- Avastin
- description
- Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min).
- interventionNames
- Drug: Avastin
Primary outcomes (6)
- measure
- Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t）
- timeFrame
- From baseline to Day 99
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhou R, Yang J, Liu Y, Zhang Q, Lu C, Tang K, Li X, Tang W, Gao E, Wu C, Dou C, Hu W. A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin(R) in healthy Chinese male subjects. Expert Opin Biol Ther. 2022 Feb;22(2):263-269. doi: 10.1080/14712598.2022.2019703. Epub 2021 Dec 27. PMID 34913787