A Phase I Clinical Trial of Bevacizumab Injection

NCT05476341 | Completed Phase 1

• 1 other identifier: ZDTQ-2017-BFZDK
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer; Lung Cancer; Ovarian Cancer; Cervical Cancer; Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Plasma concentration-area under time curve（AUC0-t）

  Area under the blood concentration time curve from 0 hour to the collection time t of the last measurable concentration

  Within 30 minutes before administration to 1680 hours (day 71)

Secondary Outcomes (6)

• Plasma concentration-area under time curve（AUC0-∞）

  Within 30 minutes before administration to 1680 hours (day 71)

• Peak concentration (Cmax)

  Within 30 minutes before administration to 1680 hours (day 71)

• Incidence of adverse events

  Within 30 minutes before administration to 1680 hours (day 71)

• Number of adverse events related to the study drug

  Within 30 minutes before administration to 1680 hours (day 71)

• Incidence of adverse events related to the study drug

  Within 30 minutes before administration to 1680 hours (day 71)

Study Arms (2)

Bevacizumab injection

EXPERIMENTAL

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).

Drug: Bevacizumab injection

Bevacizumab injection（Avastin）

ACTIVE COMPARATOR

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).

Drug: Bevacizumab injection（Avastin）

Interventions

Bevacizumab injection DRUG

Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor

Bevacizumab injection

Bevacizumab injection（Avastin） DRUG

Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor

Bevacizumab injection（Avastin）

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Healthy male subjects aged ≥ 18 and ≤ 65.
• Weight ≥ 50 kg and ≤ 80 kg, body mass index (BMI) ≥ 18 and ≤ 28kg/m2.
• 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.
• 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).

You may not qualify if:

• 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).
• Clinically significant proteinuria (routine urine examination, urine protein 2+ and above) or history of proteinuria assessed by the investigator.
• Have received any antibody or protein therapy targeting VEGF or VEGF receptor in the past 1 year.
• 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.
• Have hereditary bleeding tendency or coagulation dysfunction, or have a history of thrombosis or bleeding.
• Have a history of gastrointestinal perforation or fistula.
• 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.
• 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.
• Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or syphilis antibody are tested positive.
• Known allergy to bevacizumab or any of its excipients.
• People with known history of allergic diseases or allergic constitution.
• There was a history of blood donation 3 months before the infusion of the study drug.
• Have been treated with any other research drugs or participated in another intervention clinical trial within 2 months before screening.
• 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.
• Have a history of mental illness.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Uterine Cervical Neoplasms; Glioblastoma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 27, 2022
• Study Start: April 6, 2017
• Primary Completion: August 18, 2017
• Study Completion: August 18, 2017
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

CN (1)