A Phase I Clinical Trial of Bevacizumab Injection

This is an interventional treatment trial for Rectal Cancer Read More

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