None listed
Conditions
Interventions
Intervention1: 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
Control Intervention1: NEUPOGEN® (filgrastim): 300 mcg/0.5 ml injec
Sponsors
CuraTeQ Biologics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Endpoints Timepoint: 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
| Measure | Time frame |
|---|---|
| Immunogenicity endpoints & Safety endpoints Timepoint: Immunogenicity Time Points - 03 Time Points from Day 1 to Day 15 Safety Time points - Throughout the study duration;Pharmacodynamic endpoints Timepoint: Pharmacodynamic Time points - 29 Time points from Day 1 to Day 15 ;Pharmacokinetic endpoints Timepoint: Pharmacokinetic Time points - 30 Time Points from Day 1 to Day 15 | — |
Countries
India
Contacts
Public ContactDr Arpitkumar Prajapati
CuraTeQ Biologics Private Ltd
Outcome results
None listed