A Study to Evaluate the Safety and Pharmacokinetics of Bevacizumab After a Single Dose in Healthy Males
- Conditions
- Cervical (cervix) cancerOvarian or primary peritoneal cancerCancer - Lung - Non small cellCancer - KidneyGlioblastomaCancer - Cervical (cervix)Cancer - BrainCancer - Ovarian and primary peritonealColorectal cancerNon-small cell lung cancer
- Registration Number
- ACTRN12619001287123
- Lead Sponsor
- Syneos Health New Zealand Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 111
1) Male, non-smoker, greater than or equal to 18 and less than or equal to 55 years of age, with BMI greater than or equal to 18.5 and less than or equal to 30.0 kg/m^2 and body weight greater than or equal to 50.0 kg and less than or equal to 100 kg.
2) Healthy as defined by:
a) the absence of clinically significant illness within 4 weeks prior to dosing and surgery requiring general anesthesia within 6 months prior to dosing. Inclusion pre-dosing is at the discretion of the Investigator.
b) the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
c) hemoglobin greater than or equal to 12.8 g/dL and hematocrit greater than or equal to 0.37 L/L, and all other laboratory parameters within the normal range of the local biomedical laboratory or outside the normal range but assessed as not clinically significant by the Investigator, at screening and on Day -1.
3) Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a non-sterile female partner (sterile female partners include post-menopausal females and surgically sterile females) must be willing to use one of the following acceptable contraceptive method from dosing until at least 90 days after study drug administration:
a) simultaneous use of a male condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks);
b) simultaneous use of a male condom and, for the female partner, a diaphragm.
4) Male subjects with a pregnant partner, including subjects who have had a vasectomy must agree to use a condom throughout the study and for 90 days after study drug administration.
5) Male subjects must be willing not to donate sperm until 90 days following study drug administration.
6) Capable of consent.
7) Willing and able to comply with the requirements of the protocol and be available for the planned duration of the study.
1) Any clinically significant abnormality at physical examination at screening or on Day -1.
2) Positive test for hepatitis B, hepatitis C, or HIV at screening.
3) Positive urine drug screen, alcohol test or cotinine test at screening or on Day -1.
4) History of allergic reactions to bevacizumab, CHO cell products, other recombinant human or humanized antibodies, other related drugs, or to any excipients of the drug products.
5) History of anaphylaxis, angioedema, hypertensive crisis or infusion-related reactions following i.v. administration of a drug.
6) Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
7) Clinically significant ECG abnormalities (e.g., QTcF greater than 450 ms) or vital sign abnormalities (sustained systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 45 or over 100 bpm) at screening.
8) History of significant alcohol abuse within one year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 21 units of alcohol per week [1 unit is equal to 150 mL of wine, 360 mL of beer, or 45 mL of 40 percent alcohol]).
9) History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
10) Previous exposure to bevacizumab or biphosphonates for a medical condition or in the context of another clinical trial.
11) Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing or administration of a biological product in the context of a clinical research study within 90 days prior to dosing.
12) Use of medication other than topical products without significant systemic absorption:
a) prescription medication within 14 days prior to dosing;
b) over-the-counter products and herbal remedies, such as St. John’s wort, homeopathic and traditional medicines, within 7 days prior to dosing, with the exception of the occasional use of acetaminophen (up to 4 g daily). Vitamins, minerals and nutritional supplements may be taken at the discretion of the Investigator;
c) a depot injection or an implant of any drug within 3 months prior to dosing.
d) use of immunosuppressive drug within 6 weeks prior to dosing.
13) Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
14) Administration of immunoglobulin or blood products within 6 weeks prior to dosing.
15) History of gastrointestinal perforation or bleeding, gall bladder perforation, intra-abdominal abscess, internal fistula, hemorrhage, frequent epistaxis, clinically significant history of hemoptysis or evidence of bleeding diathesis or coagulopathy.
16) Clinically significant history of arterial or venous thromboembolic events or clinically significant peripheral vascular disease.
17) Current or past history of hypertension.
18) History or presence of any clinically significant nervous system disease including, but not restricted to any stroke, transient ischemic attack, seizures, migraine headaches o
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method