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

NCT ID: NCT05110118

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2021-01-13

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY01008

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

Group Type EXPERIMENTAL

LY01008

Intervention Type DRUG

Single intravenous injection

Avastin

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

Group Type ACTIVE_COMPARATOR

Avastin

Intervention Type DRUG

Single intravenous injection

Interventions

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LY01008

Single intravenous injection

Intervention Type DRUG

Avastin

Single intravenous injection

Intervention Type DRUG

Other Intervention Names

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Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection Bevacizumab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong Boan Biotechnology Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 34913787 (View on PubMed)

Other Identifiers

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LY01008/CT-CHN-103

Identifier Type: -

Identifier Source: org_study_id