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CTRI Number  CTRI/2023/06/054259 [Registered on: 21/06/2023] Trial Registered Prospectively
Last Modified On: 28/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two injectable formulations of anti- cancer drug Pertuzumab by studying their blood levels and safety in healthy adult male subjects  
Scientific Title of Study   A double-blind, randomised, single dose, single-centre, parallel group, two arm, comparative pharmacokinetic study of 420 mg intravenous solution for infusion of a Pertuzumab biosimilar candidate (AQ11) versus reference medicinal product (Perjeta®) in healthy, adult, male human subjects under fasting condition. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
ARL/CT/22/001 Version 04 dated 11 April 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Alpesh Patel 
Designation  Principal Investigator 
Affiliation  Accutest Research Lab (I) Pvt. Ltd. 
Address  Accutest Research Lab (I) Pvt. Ltd (Unit-I) 4th Floor, The Grand Monarch, Near Seema Hall, Anand Nagar Road, Satellite, Ahmedabad-380015, INDIA.

Ahmadabad
GUJARAT
380015
India 
Phone  07940231700  
Fax    
Email  alpesh.patel@accutestglobal.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alpesh Patel 
Designation  Principal Investigator 
Affiliation  Accutest Research Lab (I) Pvt. Ltd. 
Address  Accutest Research Lab (I) Pvt. Ltd (Unit-I) 4th Floor, The Grand Monarch, Near Seema Hall, Anand Nagar Road, Satellite, Ahmedabad-380015, INDIA.

Ahmadabad
GUJARAT
380015
India 
Phone  07940231700  
Fax    
Email  alpesh.patel@accutestglobal.com  
 
Details of Contact Person
Public Query  
Name  Vinay Onkar 
Designation  Project Manager 
Affiliation  Accutest Research Lab (I) Pvt. Ltd. 
Address  Accutest Research Laboratories (I) Pvt. Ltd., A-77, M.I.D.C., T.T.C. Industrial Area, Khairne, Navi Mumbai –400 709, Maharashtra, INDIA.

Thane
MAHARASHTRA
400709
India 
Phone  02227780718  
Fax    
Email  vinay.onkar@accutestglobal.com  
 
Source of Monetary or Material Support  
CinnaGen Research and Production Company 3rd Sq., Simindasht Industrial Area, Karaj, Alborz, I.R.IRAN. Zip Code: 3165933155  
 
Primary Sponsor  
Name  CinnaGen Research and Production Company 
Address  3rd Sq.Simindasht Industrial Area, Karaj Alborz, I.R.IRAN. Zip Code- 3165933155  
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Alpesh Patel  Accutest Research Lab (I) Pvt. Ltd. (Unit-I)  4th Floor, The Grand Monarch, Near Seema Hall, Anand Nagar Road, Satellite, Ahmedabad-380015, INDIA.
Ahmadabad
GUJARAT 		 07940231700

alpesh.patel@accutestglobal.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Riddhi Medical Nursing Home  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AQ11 Pertuzumab 420 mg concentrate for solution for infusion  Single dose of (1 x 420 mg concentrate for solution for infusion) will be administered at intravenously as a slowly (over 60 minutes). 
Comparator Agent  Perjeta (Pertuzumab) 420 mg concentrate for solution for infusion  Single dose of (1 x 420 mg concentrate for solution for infusion) will be administered at intravenously as a slowly (over 60 minutes). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1 Healthy male human subjects, age in the range of 18 – 45 years both inclusive
2 Body Mass Index between 18.5-30 Kg / m2 extremes included and Body weight is at least 50 kg
3 Subjects with normal findings as determined by baseline history, physical examination and vital sign examination (blood pressure, pulse rate, respiration rate and body temperature).
4 Subjects with clinically acceptable findings as determined by haemogram, biochemistry, urinalysis, 12 lead ECG and chest X-ray (if done).
5 Willingness to follow the protocol requirements especially abstaining from xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or grapefruit juice, any alcoholic products, the use of cigarettes and the use of tobacco products for 48.00 hours prior to dosing until after the last blood sample collection in the study and adherence to food, fluid and posture restrictions.
6 Subjects willing to sign Informed Consent Form.
7 Subjects with Left ventricular ejection fraction (LVEF) ≥ 55 %.
8 Ability to comply with study and follow-up procedures.
9 Subjects who have no evidence of underlying disease during screening medical history.
10 No history of significant alcoholism.
11 No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs (Appendix B) for the last 06 months.
12 Non-smokers, ex-smokers and moderate smokers will be included. “Moderate smokers are defined as someone smoking 10 cigarettes or less per day, ex-smokers are someone who completely stopped smoking for at least 3 months.” 
 
ExclusionCriteria 
Details  1 Known history of hypersensitivity to Pertuzumab or any of the excipients and/or related drugs.
2 Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
3 Subjects who have taken prescription medications or over-the-counter products (excluding vitamins, mineral supplements, and dietary supplements) within 28 days prior to administration of IMP.
4 Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood–forming organs, use of monoclonal antibody etc.
5 History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, haematological, gastrointestinal, endocrine, immunological or psychiatric diseases.
6 Participation in a clinical drug study or bioequivalence study 90 days prior to dosing of the present study.
7 History of malignancy or other serious diseases.
8 Blood donation 90 days prior to dosing of the present study.
9 Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
10 Subjects with any other medical or psychiatric condition that could compromise study participation.
11 Found positive in breath alcohol test.
12 Found positive in urine test for drug abuse.
13 Any contraindication to blood sampling.
14 Male subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom etc.) are acceptable.
15 Major surgery or trauma within past one year of screening or anticipated need for any surgery during the study.
16 Any other condition or circumstance that, in the judgment of the Investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
 
 
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 evaluate pharmacokinetic characteristics of two formulations of Pertuzumab  Pre dose (collected within 01.00 hour prior to dosing), 60 min (prior to end of infusion) & at 02.00, 03.00, 06.00, & 12.00 hours post-dose, Day 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 post dose 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety parameters of two formulations of Pertuzumab   Well-being assessment, blood pressure & pulse rate at 01.00, 03.00, 05.00, 08.00, 12.00 and 24.00 hrs ± 45 minutes of scheduled time. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   29/06/2023 
Date of Study Completion (India) 01/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Discussion of the Study Design

                                i.      Choice of Dose: The dose of Pertuzumab 420 mg concentrate for solution for infusion is chosen to achieve sufficient serum levels to characterize the pharmacokinetic profile of the drug. 

                              ii.      Duration of sampling: Sampling duration of 2016.00 hours is considered sufficient for adequate pharmacokinetic profiling of analyte.

                            iii.      Design; Parallel design has been selected due to long half-life and pharmacokinetic study.

                             iv.      Study Condition: The present study will be conducted under fasting condition based on the EMA guideline (GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE), In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations.

                               v.      Choice of volunteers: The healthy adult volunteers will consititute the study population. The choice and suitability of this population is discussed below.

This selection of healthy volunteers is regarded as adequate in most instances to allow extrapolation of the results to populations. Opting for healthy subjects is in accordance with EMA guideline and previous similar studies. As it is stated in the EMA guideline, GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE: “the subject population for bioequivalence studies should be selected with the aim of permitting detection of differences between pharmaceutical products. In order to reduce variability not related to differences between products, the studies should normally be performed in healthy volunteers unless the drug carries safety concerns that make this unethical. This model, in vivo healthy volunteers, is regarded as adequate in most instances to detect formulation differences and to allow extrapolation of the results to populations for which the reference medicinal product is approved.

Also, in another EMA guideline specifically developed for monoclonal antibodies such as Pertuzumab (Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues), healthy subjects are the first choice for PK studies: “Healthy volunteers are likely to have less variability in PK as target-mediated clearance may be less important than in patients.

As this is a pharmacokinetic study, the subject population of healthy volunteers is selected with the aim to minimize the variability and permit detection of differences between the two pharmaceutical products.

 
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