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COMPLETEDPHASE1

A Phase I Clinical Trial of Bevacizumab Injection

A Randomized, Double-blind, Single Dose, Parallel Comparison of Bevacizumab Injection and Avastin ® Phase I Clinical Study on the Similarity of Pharmacokinetics and Safety of Traditional Chinese Medicine in Healthy Male Volunteers

NCT05476341•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor (bevacizumab) is Avastin produced by Zhengda Tianqing Pharmaceutical Group Co., Ltd Biological similar drugs. Its mechanism is to prevent VEGF from binding to its natural receptor VEGFR, inhibit the proliferation and activation of vascular endothelial cells, and play an anti angiogenesis and anti-tumor role by binding with VEGF. A randomized, double-blind, single dose, parallel comparison of bevacizumab injection and Avastin is planned The phase I clinical study on the similarity of pharmacokinetics and safety of traditional Chinese medicine in healthy male volunteers aims to compare bevacizumab injection with Avastin The similarity of pharmacokinetics, tolerance, safety and immunogenicity.

Eligibility

Age

18 - 65 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1 Fully understand the purpose of the test, and basically understand the pharmacological effects and possible adverse reactions of the research drugs; Voluntarily sign written informed consent in accordance with the spirit of the Helsinki declaration.
•2 Healthy male subjects aged ≥ 18 and ≤ 65.
•3 Weight ≥ 50 kg and ≤ 80 kg, body mass index (BMI) ≥ 18 and ≤ 28kg/m2.
•4 Each system examination index is within the normal range, or the examination result is abnormal, but it is judged by the researcher to be of no clinical significance.
•5 The subjects agreed to use reliable contraceptives for themselves and their partners during the study period and within 6 months after the infusion of the study drug(such as abstinence, sterilization, contraceptive pills, injection of contraceptive medroxyprogesterone or subcutaneous implantation contraception, etc).

Exclusion Criteria

•1 Have a history of hypertension or abnormal blood pressure during screening / baseline measurement(Repeated measurements on the same day confirmed that systolic blood pressure \[SBP\] \> 140 mmHg and / or diastolic blood pressure \[DBP\] \> 90 mmHg).
•2 Clinically significant proteinuria (routine urine examination, urine protein 2+ and above) or history of proteinuria assessed by the investigator.
•3 Have received any antibody or protein therapy targeting VEGF or VEGF receptor in the past 1 year.
•4 Used any biological products or vaccinated with live virus vaccine within 3 months before the infusion of the study drug, or used any monoclonal antibody within 12 months.
•5 Have hereditary bleeding tendency or coagulation dysfunction, or have a history of thrombosis or bleeding.
•6 Have a history of gastrointestinal perforation or fistula.
•7 Unhealed wound ulcer or fracture, or major surgery within the first 2 months of randomization, or major surgery expected during the study period or within 2 months after the end of the study.
•8 Use prescription or over-the-counter drugs or nutritional health products, and the use time is within 5 half lives of the drugs or nutritional health products or within 2 weeks before the use of the study drugs (the time limit is whichever is longer).Herbal health products should be stopped 28 days before using the study drug.
•9 Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or syphilis antibody are tested positive.
•10 Known allergy to bevacizumab or any of its excipients.
+8 more criteria

Locations (1)

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, China

Key Dates

Start Date

April 6, 2017

Primary Completion Date

August 18, 2017

Completion Date

August 18, 2017

Last Updated

July 27, 2022

Enrollment

ACTUAL participants

Conditions

Rectal CancerLung CancerOvarian CancerCervical CancerGlioblastoma

Interventions

Bevacizumab injection

DRUG

Bevacizumab injection（Avastin）

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I Clinical Trial of Bevacizumab Injection

Inclusion Criteria

Exclusion Criteria

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