| CTRI Number |
CTRI/2026/01/100906 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to determine comparative pharmacokinetic study of BE1040V injection 400mg/ 16ml comparing with Avastin 400mg/ 16ml concentrate for solution for infusion of healthy, adult, human participants. |
|
Scientific Title of Study
|
A phase 1, double-blind, balanced, randomized, two-treatment, two-arm, single-period, single-dose, parallel, comparative pharmacokinetic study of BE1040V injection 400mg/ 16ml of AryoGen Pharmed., Iran comparing with Avastin 400mg/ 16ml concentrate for solution for infusion of Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany in normal, healthy, adult, human subjects under fasting condition. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 25-025 Version 01 Date 10 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K C Goutham Reddy |
| Designation |
Principal investigator |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Jeevan Scientific Technology Ltd. No: B-17, TIE, Phase-II, Balanagar
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
04067364700 |
| Email |
charug224@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K C Goutham Reddy |
| Designation |
Principal investigator |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Jeevan Scientific Technology Ltd. No: B-17, TIE, Phase-II, Balanagar
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
04067364700 |
| Email |
charug224@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K C Goutham Reddy |
| Designation |
Principal investigator |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Jeevan Scientific Technology Ltd. No: B-17, TIE, Phase-II, Balanagar
Hyderabad
TELANGANA
500037
India |
| Phone |
04067364700 |
| Fax |
04067364700 |
| Email |
charug224@gmail.com |
|
|
Source of Monetary or Material Support
|
| AryoGen Pharmed.
No. 140, Corner of Tajbakhsh Street, 24th Km Tehran-Karaj Makhsous road, Alborz, Iran
|
|
|
Primary Sponsor
|
| Name |
Sepideh Yazdianpour |
| Address |
AryoGen Pharmed,
No. 140, Corner of Tajbakhsh Street, 24th Km Tehran-Karaj Makhsous road, Alborz, Iran
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jeevan Scientific Technology Ltd |
Plot No. 1 and 2, Sai Krupa Enclave, Near Lanco Hills, Golconda Post Hyderabad, Ranga Reddy
Telangana - 500008, India.
Tel. No. 91-40-67364700 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K C Goutham Reddy |
Jeevan Scientific Technology Ltd |
Clinical PharmacologyDepartment Fourth floorB17 TIE Phase IIBalanagar 500037 India
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
04067364700
04067364700
charug224@gmail com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Avastin 400mg/ 16ml concentrate for solution for infusion |
Strength 400mg/ 16ml Solution for injection Dose of 1 mg/kg |
| Intervention |
BE1040V injection 400mg/ 16ml |
Strength 400mg/ 16ml Solution for injection
Dose of 1 mg/kg
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adult human subjects 18 to 45 years of age both inclusive and weight 50 BMI 18.5 to 30.0 kg per m² including both.
Acceptable findings during registration and screening including medical history physical examination laboratory evaluations 12 lead ECG and chest X-Ray postero-anterior view.
Non smokers and non alcoholic.
values within normal ranges for laboratory parameters upon evaluation by the investigator or physician for any of the following tests.
Subjects able to communicate effectively.
Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
Subject willing to abstain from all kinds of grapefruit or caffeine or xanthine containing foods or juices from 72.00 hours prior to admission until the last post dose blood sample collection in study period.
|
|
| ExclusionCriteria |
| Details |
Volunteers having known history of contraindication or hypersensitivity e.g. anaphylaxis to Bevacizumab or related group of drugs. History of significant asthma urticaria or other allergic type reactions after taking aspirin or other NSAIDs. History of seizures diabetes migraine hypertension cardiovascular pulmonary neurological or psychiatric disease or disorder dermatological endocrine immunological hepatic renal hematopoietic gastrointestinal ongoing infectious diseases or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician. History of cerebral infarction myocardial infarction and pulmonary embolism.
History of gastrointestinal GI inflammation bleeding ulceration and perforation of the stomach small intestine or large intestine.
History or evidence of exfoliative dermatitis Stevens Johnson syndrome SJS toxic epidermal necrolysis TEN Angioedema and Bullous Pemphigoid.
Any known enzyme inducing or inhibiting drug taken within 14 days before the study. Taking any biological drugs within 3 months before the study.
Participation in a drug research study within 90 days prior to dosing of this study.
Blood loss or whole blood donation within 90 days prior to drug administration. Consumption of high caffeine. more than 5 cups of coffee or tea per day. History of addiction to any recreational drug or drug dependence. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of study period e.g. fasting due to religious reasons. History of dehydration from diarrhea vomiting or any other reason within a period of 48.00 hours prior to study admission.
Positive results for drugs of abuse benzodiazepines cocaine opioids amphetamines cannabinoids and barbiturates in urine during the admission of study period. Positive results for alcohol consumption test breath alcohol or urine alcohol during the admission of study period.
History or presence of any bleeding disorder.
Difficulty with donating blood. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg. Pulse rate less than 70 beats per minute or more than 100 beats per minute.
Use of any prescription drugs within 14 days or at least 5 half lives of the compound whichever period is longer prior to study admission. and Use of herbal medicines and any OTC medications including vitamins within 14 days or at least 5 halflives of the compound whichever period is longer prior to study admission
History of alcohol abuse and or dependence within six months of the screening visit or History of drug abuse or use of illegal drugs within 90 days prior to admission of this study.
Female subjects demonstrating a positive pregnancy screen.
Female volunteer who is pregnant or currently breast feeding.
Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate pharmacokinetic similarity of test and reference product in normal, healthy, adult, human subjects under fasting conditions. |
In study period, pre-dose (00.00 hour) and at 00.50, 01.00, 01.50 (end of infusion), 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 08.00, 12.00, 24.00 (day 2), 48.00 (day 3), 96.00* (day 5), 168.00* (day 8), 312.00* (day 14), 480.00* (day 21), 648.00* (day 28), 984.00* (day 42), 1320.00* (day 56), 1656.00* (day 70), 1992.00* (day 84) and 2376.00* (day 100) hours post dose into plain vacutainer in study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the safety & tolerability of single intravenous dose of test & reference product in normal, healthy, adult, human subjects under fasting conditions. |
Predose, 02.00, 05.00, 11.00, 25.00 & 33.00, 96.00 (day 5), 168.00 (day 8), 312.00 (day 14), 480.00 (day 21), 648.00 (day 28), 984.00 (day 42), 1320.00 (day 56), 1656.00 (day 70), 1992.00 (day 84) & 2376.00 (day 100) hours & end of the study |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
20/01/2026 |
| 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="3"
Days="11" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participants will undergo a screening procedure comprising clinical examination, recording of electrocardiogram and laboratory investigation of blood as well as urine which will be valid for 21days from the day of screening. Radiological investigations (chest X-ray) will be repeated, if notdone in the past 6 months or if clinically indicated at the time of screening. Participants must be enrolled in the study only after providing written informed consent. Selection of Participants for the study will be done based on assessment against the inclusion and exclusion criteria. |