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CTRI Number  CTRI/2025/03/083125 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to compare the pharmacokinetic, pharmacodynamics, safety and immunogenicity for two formulations of Pegfilgrastim. 
Scientific Title of Study   Single dose study to compare pharmacokinetic, pharmacodynamic, immunogenicity and safety of BP14 (Pegfilgrastim) 6 mg/0.6 mL solution in single use pre-filled syringe and US-Licensed Neulasta (Pegfilgrastim) 6 mg/0.6 mL solution for Injection in healthy adult male subjects 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
C1B04734 version No 01 dated 17.08.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dhruv Patel 
Designation  Principal Investigator 
Affiliation  Cliantha Research Limited, 
Address  Cliantha Research Limited, Cliantha Corporate, TP 86 FP 28/1 Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India

Ahmadabad
GUJARAT
382210
India 
Phone  2717698500  
Fax    
Email  dppatel@cliantha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arpitkumar Prajapati 
Designation  General Manager 
Affiliation  CuraTeQ Biologics Private Ltd 
Address  CuraTeQ Biologics Private Ltd CuraTeQ Biologics Private Ltd. Unit XVII, SyNo.77&78, Indrakaran (v) Sangareddy Dist Hyderabad -502329 TELANGANA 500081 India

Hyderabad
TELANGANA
500081
India 
Phone  08455255222  
Fax    
Email  Arpitkumar.Prajapati@curateqbio.com  
 
Details of Contact Person
Public Query  
Name  Dr Arpitkumar Prajapati 
Designation  General Manager 
Affiliation  CuraTeQ Biologics Private Ltd 
Address  CuraTeQ Biologics Private Ltd CuraTeQ Biologics Private Ltd. Unit XVII, SyNo.77&78, Indrakaran (v) Sangareddy Dist Hyderabad -502329 TELANGANA 500081 India

Hyderabad
TELANGANA
500081
India 
Phone  08455255222  
Fax    
Email  Arpitkumar.Prajapati@curateqbio.com  
 
Source of Monetary or Material Support  
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India 
 
Primary Sponsor  
Name  CuraTeQ Biologics Private Ltd. 
Address  Galaxy, Floors: 22-24, Plot No. 1, Survey No. 83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Rangareddy Dist., Hyderabad, Telangana, India, 500 081  
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 Dhruv Patel  Cliantha Research Limited  Cliantha Research Limited Cliantha Corporate, TP 86 FP 28/1 Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India
Ahmadabad
GUJARAT 		 91-2717-698500

dppatel@cliantha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Riddhi Medical Nursing Home Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adult male Subjects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BP14 (Pegfilgrastim)  6 mg/0.6 mL (10 mg/mL) pre-filled syringe Duration: Single dose  
Comparator Agent  US- Licensed Neulasta®  6 mg/0.6 mL (10 mg/mL) solution for Injection Duration: Single dose  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  Volunteers must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
1) Age: 18 to 55 years old, both inclusive.
2) Gender: Male.
3) BMI: 18.5 to 30.0 kg/m2 , both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
4) Volunteers having body weight 50 kg or more and 100 kg and less
5) Volunteers is considered to be in good health, as determined by:
a) The absence of clinically significant illness or surgery within 4 weeks prior to dosing.
b) The absence of a clinically significant history of disease.
c) The absence of a clinically significant history of skin disorders, including psoriasis
6) Able to communicate effectively with study personnel.
7) Willing to provide written informed consent to participate in the study 
 
ExclusionCriteria 
Details  Volunteers must not be enrolled in the study if they meet any one of the following criteria:
1) History of allergic responses to Pegfilgrastim, filgrastim, Escherichia coli (E. coli)- derived proteins or other related drugs, or any of its formulation ingredients. History of allergic reactions or hypersensitivity to acetate/acetic acid, polysorbate 20, or sorbitol.
2) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording and ultrasonography abdomen].
3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
4) History or presence of bronchial asthma.
5) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
6) Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
7) Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication
8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
9) Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
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.
12) Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
13) Intolerance to venipuncture
14) 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.
15) Institutionalized volunteers.
16) Use of any prescribed medications within 14 days prior to the first dose of study medication.
17) Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
18) Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
19) Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine containing sodas, colas, etc.), cigarettes and tobacco containing products, recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
20) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
21) Volunteer with history of cancer.
22) Acute viral or bacterial infection within 1 month prior to initial dosing only if considered clinically significant in the opinion of the principal or sub-investigator.
23) History of any clinically significant disease or condition that, in the opinion of the principal or sub-investigator or physician, would render them unsuitable for inclusion in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pharmacokinetics Parameters : Cmax, AUCt, AUCi, Tmax, Kel, AUC_%Extrap_obs and tHalf
Pharmacodynamic Parameters : Amax, AUEC(0-t)
Immunogenicity Parameters : Anti-Drug Antibody (ADA) 		 Pharmacokinetic Timepoints
19 timepoints from day 1 to day 20
Pharmacodynamic Timepoints
19 timepoints from day 1 to day 20
Immunogenicity Timepoints:
03 timepoints from day 1 to day 20
Safety endpoints:
Throughout the study
 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety & tolerability of the investigational products  Safety : Safety events review & analysis 
 
Target Sample Size   Total Sample Size="184"
Sample Size from India="184" 
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)   07/04/2025 
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="6"
Days="0" 
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   This will be a phase 1, double blind, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose study to compare pharmacokinetic, pharmacodynamic, immunogenicity and safety in healthy adult male subjects. The objective of the study is to compare and evaluate the pharmacokinetic, pharmacodynamic, immunogenicity and safety of BP14 (Pegfilgrastim) 6 mg/0.6 mL solution in single use pre-filled syringe with that of US- Licensed Neulasta® (Pegfilgrastim) 6 mg/0.6 mL solution for Injection administered through subcutaneous route in healthy, adult, male subjects. 
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