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A Phase I Clinical Trial of Bevacizumab Injection

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 65 Years
Gender Male
More Inclusion & Exclusion Criteria

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.
  • - 11 People with known history of allergic diseases or allergic constitution.
  • - 12 There was a history of blood donation 3 months before the infusion of the study drug.
  • - 13 Have been treated with any other research drugs or participated in another intervention clinical trial within 2 months before screening.
  • - 14 Have a history of alcohol or drug abuse within 12 months before screening; The subjects were unable to quit drinking within 72 hours before administration and throughout the trial.
  • - 15 Have a history of mental illness.
  • - 16 Subjects whose spouses plan to conceive.
  • - 17 Unable to follow the protocol requirements to complete the study during the study.
- 18 Other researchers think it is not suitable to be included in the group

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05476341
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rectal Cancer, Lung Cancer, Ovarian Cancer, Cervical Cancer, Glioblastoma
Arms & Interventions

Arms

Experimental: Bevacizumab injection

On the first day, bevacizumab injection was given, 3mg/kg each time, diluted to 100ml of 0.9% sodium chloride injection, mixed evenly, and then intravenous infusion for 90 minutes (±15 minutes).

Active Comparator: Bevacizumab injection（Avastin）

On the first day, Avastin injection was given, 3mg/kg of which was diluted to 100ml of 0.9% sodium chloride injection. After mixing evenly, it was infused intravenously for 90 minutes (±15 minutes).

Interventions

Drug: - Bevacizumab injection

Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor

Drug: - Bevacizumab injection（Avastin）

Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Changchun, Jilin, China

Status

Address

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, 130000

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