Pharmacokinetic study of ZRC-3113 (Zydus Bevacizumab) and â??Avastinâ?¢â?? (Bevacizumab) in Healthy, Adult, Male subjects
- Registration Number
- CTRI/2020/01/022946
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Age:18 to 45 years old, both inclusive.
2)Sex:Male
3)BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive
4)Volunteer having body weight of at least 50 kg.
5)Non smokers and non tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
6)Able to communicate effectively with study personnel.
7)Able to signed and dated written informed consent prior to any study-specific procedures, Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal or sub-investigator.
8)Male Volunteers should be willing to use a condom (with spermicide), 02 acceptable contraceptives such as intrauterine device (IUD); oral, transdermal, injected, or implanted contraceptive; condoms; occlusive cap (diaphragm or cervical vault caps); spermicidal foam/gel/cream, etc (with their female partner) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the first day of study medication administration until 6 months after receiving the last administration of study medication [ZRC-3113 (Zydus Bevacizumab), â??Avastin•â?? (Bevacizumab)] administration.
1)History of allergic responses/exposure to bevacizumab, Chinese Hamster Ovary (CHO) cell products or other recombinant proteins or antibodies or other related drugs, or antibodies.
2)Participation in a study with Bevacizumab or â??Avastin•â?? (Bevacizumab) or small molecule inhibitors against VEGF or VEGF receptors or any prior exposure to these drugs or any other monoclonal antibody drugs.
3)Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), vital signs, laboratory evaluations, ECG, Echocardiography, ophthalmic examination (slit lamp examination, fundoscopy and tonometry) and chest X-ray recording].
4)Any disease or condition like diabetes, psychosis or others which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
5)History or presence of bronchial asthma.
6)Use of any hormone replacement therapy within 3 months prior to the study medication administration.
7)A depot injection or implant of any drug within 3 months prior to the study medication administration.
8)Use of enzyme-modifying drugs within 30 days prior to the study medication administration.
9)History or evidence of drug dependence or of alcoholism or of significant alcohol use.
10)History of difficulty with donating blood or difficulty in accessibility of veins.
11)A positive hepatitis screen (includes subtypes B & C).
12)A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
13)Volunteers who have received a known Investigational drug within 03 months of the administered drug prior to the study medication administration or have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
14)Intolerance to venipuncture
15)Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Sub-Investigator, could contraindicate the volunteerâ??s participation in this study.
16)Institutionalized volunteers.
17)Volunteers have history of perforation, ulcers, gastro oesophageal reflux, inflammatory bowel disease, diverticular disease, or any fistulae.
18)Volunteers have history of nephrotic syndrome.
19)Volunteer having Serum creatinine higher than the upper limit of reference range.
20)Volunteer having any planned surgery or dental procedures within 4 months after administration of Investigational medical product.
21)Volunteers who have history of surgical intervention or injury or dental procedure within 2 months before dosing.
22)Volunteers who have total WBC and neutrophil less than the lower limit of reference range.
23)Volunteers who have albumin present in urine during screening.
24)Volunteers who have history or presence of active bleeding such as recent or recurrent gastrointestinal bleeding, peptic ulcer, due to recent trauma, recent surgery, CNS hemorrhage. Any episode of Hemoptysis or epistaxis within 6 months prior to administration of Investigational Medicinal products.
25)Volunt
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method