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

NCT05110118 | Completed Phase 1

• 1 other identifier: LY01008/CT-CHN-103
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

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

  From baseline to Day 99

• Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞）

  From baseline to Day 99

• Maximum (peak) plasma concentration（Cmax）

  From baseline to Day 99

• Chloride（CL）

  From baseline to Day 99

• Terminal elimination half-life（t1/2）

  From baseline to Day 99

• Apparent volume of distribution（Vd）

  From baseline to Day 99

Secondary Outcomes (7)

• Adverse Events(AEs)

  From baseline to Day 99

• Vital signs

  From baseline to Day 99

• Physical examinations

  From baseline to Day 99

• Clinical laboratory tests

  From baseline to Day 99

• 12-lead ECGs

  From baseline to Day 99

Study Arms (2)

LY01008

EXPERIMENTAL

Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min).

Drug: LY01008

Avastin

ACTIVE COMPARATOR

Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min).

Drug: Avastin

Interventions

LY01008 DRUG

Single intravenous injection

Also known as: Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection

LY01008

Avastin DRUG

Single intravenous injection

Also known as: Bevacizumab

Avastin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Boan Biotechnology Co., Ltd: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Related Publications (1)

• Zhou 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 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: August 4, 2020
• Primary Completion: January 13, 2021
• Study Completion: January 13, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)