| CTRI Number |
CTRI/2025/07/090160 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative immunogenicity and safety study of BP14 and Neulasta® in healthy adult male subjects |
|
Scientific Title of Study
|
Multiple dose study to compare immunogenicity and safety of BP14 (Pegfilgrastim) 6 mg/0.6 mL solution in single use prefilled 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 |
| C1B04735, Version 01, 17 August 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhruv Patel MBBS |
| Designation |
Principal investigator |
| Affiliation |
Cliantha Research Limited |
| Address |
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
382210
India |
| Phone |
|
| 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
|
| CuraTeQ Biologics Private Ltd. Galaxy, Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City, Hyderabad, Telangana, India, 500081 |
|
|
Primary Sponsor
|
| Name |
CuraTeQ Biologics Private Ltd |
| Address |
Galaxy, Floors 22-24, Survey No. 83/1, Hyderabad Knowledge City, Hyderabad, Telangana, India, 500081 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
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 Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad-382210, Gujarat, India Ahmadabad GUJARAT
Ahmadabad
GUJARAT |
91-2717-698500
dppatel@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Riddhi Medial Nursing Home |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult male Subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BP14 (Pegfilgrastim)
Injection 6 mg/0.6 mL
|
6 mg/0.6 mL (10 mg/mL) pre-filled syringe
Duration: Two doses
|
| Comparator Agent |
Neulasta® Injection 6 mg/0.6 mL |
6 mg/0.6 mL (10 mg/mL) solution for Injection
Duration: Two doses
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
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) Volunteer 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 |
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.
13) 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.
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) Use of any prescribed medications within 14 days prior to the first dose of study medication.
18) Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
19) Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
20) 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.
21) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
22) Volunteer with history of cancer.
30) 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 |
| Treatment emergent ADA incidence rate between BP14 (Pegfilgrastim) and US- Licensed Neulasta® (Pegfilgrastim) |
from day 1 to day 58 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immunogenicity: Incidence of anti-PEG antibodies, anti-G-CSF antibodies |
from day 1 to day 58 |
| Safety: TEAE, TESAEs, AESIs, Injection site reactions, clinical laboratory values, vital signs, physical examinations, & ECG |
throughout the study |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
21/07/2025 |
| 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 Yet Recruiting |
| 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 is a double blind, randomized, two-cycle, two-treatment, parallel, balanced, multiple dose study to compare 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. The objective of the study is to compare and evaluate the immunogenicity 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; and to monitor the safety and tolerability of the investigational products |