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CTRI Number  CTRI/2020/01/022946 [Registered on: 27/01/2020] Trial Registered Prospectively
Last Modified On: 15/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pharmacokinetic study of ZRC-3113 (Zydus Bevacizumab) and ‘Avastin™’ (Bevacizumab) in Healthy, Adult, Male subjects 
Scientific Title of Study   A randomized, double-blind, parallel, single dose comparative pharmacokinetic study of ZRC-3113 (Zydus Bevacizumab) and ‘Avastin™’ (Bevacizumab) in healthy, adult, male subjects.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mayur Soni 
Designation  MBBS 
Affiliation  Cliantha Research Limited 
Address  Sigma-1 Corporate, B/H. Rajpath Club, Opposite Mann Party Plot, Off. S.G Highway, Bodakdev, Ahmedabad-380 054, Gujarat, India

Ahmadabad
GUJARAT
380054
India 
Phone  079-66135601  
Fax  079-66135602  
Email  msoni@cliantha.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Taufik Momin 
Designation  Principal Scientist  
Affiliation  Cadila Healthcare Limited  
Address  Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad-382213 Gujarat

Ahmadabad
GUJARAT
382213
India 
Phone  02717-665555  
Fax  02717-665355  
Email  Taufik.Momin@zyduscadila.com  
 
Details of Contact Person
Public Query  
Name  Dr Taufik Momin 
Designation  Principal Scientist  
Affiliation  Cadila Healthcare Limited  
Address  Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad-382213 Gujarat


GUJARAT
382213
India 
Phone  02717-665555  
Fax  02717-665355  
Email  Taufik.Momin@zyduscadila.com  
 
Source of Monetary or Material Support  
Cadila Healthcare Ltd. Zydus Tower Satellite Cross Road, Ahmedabad 380015 Gujarat, India  
 
Primary Sponsor  
Name  Cadila Healthcare Ltd  
Address  Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad-382213 Gujarat, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mayur Soni  Cliantha Research Limited  Sigma-1 Corporate, Behind Rajpath Club, Opposite Mann Party Plot, Sarkhej Gandhinagar Highway, Bodakdev, Ahmedabad-380 054, Gujarat, India.
Ahmadabad
GUJARAT 		 079-66135601
079-66135602
msoni@cliantha.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Zydus Hospital Ethics Committee,Zydus Hospital & Healthcare Research Pvt.Ltd,Near sola bridge,Thaltej,S.G.Highway,Ahmedabad-380054,Gujarat,India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Avastin (Bevacizumab)  Dose-1 mg/kg,Frequency-single,Route-IV infusion 
Intervention  ZRC-3113 (Zydus Bevacizumab  Dose-1 mg/kg,Frequency-single,Route-IV infusion  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  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), ‘Avastin™’ (Bevacizumab)] administration.
 
 
ExclusionCriteria 
Details  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 ‘Avastin™’ (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 volunteer’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) Volunteer having Prothrombin Time, Activated Partial Thromboplastin Time and INR 1.1 times higher than the upper limit of normal range during screening.
26) Volunteers who have presence of a non-healing wound or fracture or wound dehiscence.
27) Volunteers who have medically significant dental disease or dental neglect with signs and or symptoms of local or systemic infection that would likely require a dental procedure during the course of study.
28) Volunteers who have received a live or attenuated vaccine within 3 months prior to screening, or have the intention to receive a vaccine during the study or intend to travel to a region where a vaccination will be required due to endemic disease within 4 months of dosing.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the pharmacokinetics of ZRC-3113 (Zydus Bevacizumab) to ‘Avastin™’ (Bevacizumab) Roche after administration of single intravenous (IV) infusion in healthy, adult, male subjects.   To compare the pharmacokinetics of ZRC-3113 (Zydus Bevacizumab) to ‘Avastin™’ (Bevacizumab) Roche after administration of single intravenous (IV) infusion in healthy, adult, male subjects.  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the immunogenicity of ZRC-3113 (Zydus Bevacizumab) to ‘Avastin™’ (Bevacizumab) Roche in healthy, adult, male subjects.   Day 0:
Pre--dose (0.0 hour) prior to infusion

Day 21, 42, 56, 84 and 100:
At 504.0, 1008.0, 1344.0, 2016.0 and 2400.0 after start of infusion
 
To assess and compare the safety and tolerability of ZRC-3113 (Zydus Bevacizumab) to ‘Avastin™’ (Bevacizumab) Roche in healthy, adult, male subjects.   Vials:0.5, 1.0, 1.5 (± 15 minutes), 3.0, 8.0, 12.0, 24.0, 36.0, 48.0 and 60.0 hours (± 30 minutes) after start of infusion
12-lead ECG will be recorded at pre-dose (within 120 minutes prior to infusion), 1.0, 3.0, 6.0 and 12.0 hours (± 40 minutes) after start of infusion and prior to check-out  
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   03/02/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a randomized, double-blind, single dose, two-arm, parallel study to compare the pharmacokinetics (PK), immunogenicity and safety of two preparations of Bevacizumab - namely of ZRC-3113 (Zydus Bevacizumab) and ‘Avastin™’ (Bevacizumab).  

 
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