| CTRI Number |
CTRI/2024/09/073942 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate to compare the pharmacokinetic, pharmacodynamics, safety and immunogenicity for two formulations of Filgrastim |
|
Scientific Title of Study
|
A randomized, phase 1, double-blind, single-period, two-treatment, parallel, Multiple dose, balanced, comparative pharmacokinetic, pharmacodynamic, safety and immunogenicity assessment of BP13 (Filgrastim) 300 mcg/0.5 ml PFS with US Licensed - NEUPOGEN® (filgrastim) 300 mcg/0.5 mL in a single-dose prefilled syringe in healthy adult male Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C1B03843, Version 02, March 14, 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. 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. 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 Limited |
| Address |
Galaxy,Floors: 22-24, Plot No. 1,Survey No: 83/1, Hyderabad
Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad 500032,Telangana, India |
| 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 |
2717698500
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy male volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BP13 (Filgrastim) |
300 mcg/0.5 ml injection
Duration: Single dose of 5 mcg/Kg at every 24 hours from Day 01 to Day 05 |
| Comparator Agent |
NEUPOGEN® (filgrastim) |
300 mcg/0.5 ml injection
Duration: Single dose of 5 mcg/Kg at every 24 hours from Day 01 to Day 05 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Subject is 18 to 55 years of age both inclusive at the time of providing the informed consent form.
Subject is healthy as determined by medical evaluation including comprehensive medical history, physical examination, vital sign measurements, 12 lead electrocardiogram and clinical laboratory tests, unless considered not clinically significant by the Investigator.
Subject has body mass index within the range 18.5 to 30.0 kg/m2 (both inclusive).
Subject is a male.
Subjects having body weight greater or equal to 60 kg and less or equal to 100 kg.
The subject must agree to use a highly effective double form of contraception as detailed below during the study and for at least 90 days after the last dose of IMP and refrain from donating sperm during this period.
Male subjects with female partners (both childbearing and non-child bearing potential), male subjects with pregnant partners, and male subjects with male partners are eligible to participate if they agree to TWO of the following during the protocol-defined time frame. A. Non-vasectomized male subjects with female partners of childbearing potential must agree to use a form of contraception (i.e., condom, hormonal contraceptive, diaphragm, intrauterine contraception) from screening until 90 days after the last dose of the IMP. B. Male subjects (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last dose of the IMP. C. All male subjects must be willing not to donate sperm until 90 days after the last dose of the IMP. D. Male subjects with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle. E. Male subjects who practice abstinence are eligible when this is their preferred and usual lifestyle and must continue to practice abstinence for the duration of the study.
Subject is capable of and willing to give signed informed consent and in compliance with the requirements and restrictions listed in the ICF.
Non-smokers or casual smokers who smoke no more than 10 cigarettes (or equivalent quantity of any other nicotine containing substance) per week. Subject must abstain from smoking during the inpatient stay of the study.
Ability and willingness to abstain from alcohol during the study.
All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include: a) A physical examination (clinical examination) with no clinically significant finding. b) Results within normal limits or clinically non-significant for the Hematology, Biochemistry, Urinalysis, Immunological Tests and Additional tests. Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion.
All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
|
|
| ExclusionCriteria |
| Details |
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 80, or sorbitol.
History of chronic cough, fever or acute respiratory illness within 4 weeks prior to the day of IMP administration.
Current or previous cancer, diabetes, or any clinically significant ultrasonography abdomen, cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or any other disorder clinically relevant as judged by the Investigator.
As judged by the Investigator, any past or concurrent medical conditions, which in the opinion of the Investigator would potentially increase the subject’s risks or affect the evaluation of study results.
Any history of major surgery that in the opinion of the Investigator would interfere with the study or place the subject at risk.
Hereditary fructose and/or sorbitol intolerance.
Any history of previous exposure to pegfilgrastim or filgrastim, granulocyte-colony stimulating factor (GCSF) or any analogue of these.
Hypersensitivity to the constituents of Neupogen®, filgrastim (acetate, polysorbate 80, sodium and sorbitol) or hypersensitivity to Escherichia. Coli derived proteins.
Treatment with non-topical medications within 5 days prior to admission to the study center (Day -1), with the exception of hormonal contraceptives, multivitamins, vitamin C, food supplements and a limited amount of paracetamol(acetaminophen), which may be used throughout the study.
Participation in a drug study involving hemopoietic growth factors, monoclonal antibodies, or immunoglobulins in the last 3 months prior to first administration of IMP or currently is on a follow-up visit for any other drug studies.
Unable to follow protocol instructions in the opinion of the Investigator.
Donation or loss of more than 500 mL of blood over a period of 90 days prior to first IMP administration.
Positive screen for alcohol test (by blood sample/ urine sample) and/or positive Urine scan for drugs of abuse (marijuana-THC, amphetamine-AMP, barbiturates-BAR, cocaine-COC, benzodiazepines-BZO and morphine-MOP) at check in (Day -1), unless a positive result is attributable to a documented use of a concomitant medication and is approved by the Investigator. (In case of positive urine drug screen at check in (Day -1), at the Investigator’s discretion, the drug screen test may be repeated in the possible instance of a false positive due to i.e., poppy seed consumption).
History of alcohol abuse or excessive intake of alcohol in the past 1 year as judged by the Investigator.
Positive screen on hepatitis B surface antigen (HbsAg), hepatitis B core antibody, anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies at screening.
Family history of acute myeloid leukemia or subjects with splenomegaly (spleen size greater than 13 cm in the craniocaudal dimension by ultrasound) at baseline, or with sickle cell disease.
Volunteer having Total WBC count, Absolute Neutrophil Count (ANC) values outside of normal range during screening.
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, dietary items that have effect on P450 enzymes (e.g. pomegranate, star fruit, seville oranges) & PGP (P-Glycoprotein) efflux pump (e.g. St. John’s wort) within 48 hours prior to the first dose of study medication.
Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
Volunteer having Platelets counts lower than the lower limit of normal range during screening.
Volunteer having Serum creatinine and serum bilirubin higher than the upper limit of normal range during screening.
Volunteer having SGPT, SGOT and Alkaline phosphatase higher than 1.1 times of upper limit of normal range during screening.
Volunteers who have any past exposure to recombinant human G-CSF products and/or a known history of prior treatment with blood-cell colony stimulating factors, interleukins or interferons.
Volunteers who are on a special diet or who have self-reported a weight loss of more than 15 pounds (6.8 kg) within 1 month prior to initial dosing.
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.
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.
Volunteers who have received a known investigational drug within 90 days prior to the first dose of study medication.
Use of any prescribed medications within 14 days prior to the first dose of study medication.
Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
Volunteer having sitting systolic blood pressure less than 100 mmHg or greater than 140 mmHg or sitting diastolic blood pressure less than 60 mmHg or greater than 90 mmHg and pulse rate less than 60 or greater than 100 per minute during screening. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pharmacokinetic Endpoints
|
PK Time points - 30 time points from Day 1 to Day 15
PD time points - 29 time points from Day 1 to Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pharmacokinetic endpoints
|
Pharmacokinetic Time points - 30 Time Points from Day 1 to Day 15
|
Pharmacodynamic endpoints
|
Pharmacodynamic Time points -
29 Time points from Day 1 to Day 15
|
Immunogenicity endpoints & Safety endpoints
|
Immunogenicity Time Points - 03 Time Points from Day 1 to Day 15
Safety Time points - Throughout the study duration |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Filgrastim is a recombinant granulocyte-colony stimulating factor (rG-CSF) that acts on hematopoietic cells by binding to specific cell surface receptors stimulating their proliferation and differentiation. BP13 is being developed by Cura TeQ Biologics Private Limited as a filgrastim biosimilar for treatment of chemotherapy-induced-neutropenia. This study is aimed to compare the Pharmacokinetics (PK) and Pharmacodynamics (PD) of BP13 (Filgrastim) 300 mcg/0.5 ml PFS with US Licensed - NEUPOGEN® (filgrastim) 300 mcg/0.5 mL in a single-dose prefilled syringe in healthy adult male subjects. |