CTRI/2024/09/073942已完成1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Pharmacokinetic Endpoints
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •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.
- •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.
- •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.
- •Male subjects with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
- •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 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.
排除标准
- •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).
- •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.
- •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.
- •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.
结局指标
主要结局
Pharmacokinetic Endpoints
时间窗: PK Time points - 30 time points from Day 1 to Day 15 | PD time points - 29 time points from Day 1 to Day 15
次要结局
- Pharmacokinetic endpoints
- Pharmacodynamic endpoints
- Immunogenicity endpoints & Safety endpoints
研究者
Dr Dhruv Patel
Cliantha Research Limited
研究点 (1)
Loading locations...
相似试验
尚未招募
2/3 期
Comparative study of low dose versus standard dose of peg gcsf in patient receiving chemotherapy in breast cancer.CTRI/2025/01/079576Army Hospital Research and referral New Delhi382
尚未招募
4 期
Role of G-CSF in preventing oral ulcers in cancer patients receiving radiation therapy.CTRI/2024/09/074468VMMC and Safdarjung hospital70
已完成
不适用
Pharmacokinetics of Granulocyte Colony Stimulating Factor in the Breast Milk of Volunteer Peripheral Blood Stem Cell DonorNormal PhysiologyNCT02322151National Institutes of Health Clinical Center (CC)4
已完成
3 期
Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast CancerNeutropeniaNCT05283616Cancer Institute and Hospital, Chinese Academy of Medical Sciences122
尚未招募
3 期
A clinical study to assess the effect of Lupin’s Filgrastim as compared to Neupogen®(Amgen) administered after chemotherapy to prvent Neutropenia caused by chemotharapy in patients with non-myeloid malignanciesCTRI/2011/05/001748LUPIN LIMITED BIOTECHNOLOGY DIVISION98