None listed
Conditions
Brief summary
The purpose of this study is to compare the pharmacokinetics (what the body does to a drug), Pharmacodynamics (effect of drugs on the body), immunogenicity (ability to provoke an immune response) and safety of BP13 with Neupogen in healthy males. Who is it for? Healthy male aged 18 to 55 years. Study details All participants in this study will undergo treatment utilizing a double-blind, randomized, parallel, controlled study design. The total study duration for each subject is expected to be approximately 15 days (excluding the 28-day screening period). This drug is recommended for use in cancer patients undergoing chemotherapy, to reduce the incidence of infection. All participants will undergo regular blood tests and safety assessments throughout the study, in order to evaluate how the body responds to the drug. We hope that BP13 (filgrastim) will be comparable to Neupogen, warranting further investigational trials to evaluate its efficacy in cancer patients.
Interventions
The treatments will be BP13 (Treatment A) and Neupogen (Treatment B), subjects will receive daily 5 mcg/kg/day subcutaneous (SC) injection of either BP13 or Neupogen from Day 1 to Day 5.
When participants are dosed at the site, they will receive investigational product (IP) directly from the Investigator or designee, under medical supervision.
Sponsors
CURATEQ BIOLOGICS PRIVATE LIMITED
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject is 18 to 55 years of age inclusive, at the time of signing the informed consent form (ICF). 2. Subject is healthy as determined by medical evaluation including comprehensive medical history, physical examination, vital sign measurements, cardiac monitoring (12-lead electrocardiogram [ECG]), and clinical laboratory tests (including iron status transferrin saturation greater than or equal to 15%), unless considered not clinically significant by the Investigator. At Screening, a subject with a supine/semi supine systolic BP > 145 mmHG and/or a supine/semi supine diastolic BP > 90 mmHg. Two repetitions on the same day are allowed and, in this case, the mean of the 3 measurements will guide eligibility. 3. Subject has body mass index (BMI) within the range 18 – 35 kg/m2 (inclusive). Body weight should be less than or equal to 95 kg. 4. Subject is a male. 5. The subject must agree to use a highly effective double form of contraception during the study and for at least 90 days after the last dose of IMP and refrain from donating sperm during this period. 6. Subject is capable of and willing to give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 7. 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. 8. Ability and willingness to abstain from alcohol during the study. 9. Screening laboratory results (hematology, biochemistry, coagulation, iron profile, and urinalysis) should be within normal limits, or any abnormalities should not be clinically significant, as determined by the Investigator. Repeat laboratory tests are permitted at the Investigator’s discretion. 10. To rule out symptoms of glandular fever, subjects must test negative for antibodies to the Epstein-Barr virus at screening for study participation. 11. Must have normal organ function as per the Investigator’s judgment. 12. Must have normal liver function as determined by serum bilirubin, alkaline phosphatase (ALP), and transaminases (alanine aminotransaminase [ALT] and aspartate aminotransaminase [AST]) the upper limit of normal (ULN) unless deemed not clinically significant by the Investigator. The ULN is left to the discretion of the Investigator. 13. Must have adequate renal function defined as serum creatinine less than or equal to 1.5 x ULN.
Exclusion criteria
1. Current or previous cancer, diabetes, or any clinically significant cardiovascular, metabolic, renal, hepatic, gastrointestinal, hematologic, respiratory, dermatological, neurological, psychiatric, or any other disorder clinically relevant as judged by the Investigator. 2. History of chronic cough, fever or acute respiratory illness within 4 weeks prior to the day of IMP administration. 3. 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. 4. Any history of major surgery that in the opinion of the Investigator would interfere with the study or place the subject at risk. 5. Hereditary fructose and/or sorbitol intolerance. 6. Any history of previous exposure to pegfilgrastim or filgrastim, GCSF, or any analogue of these. 7. Hypersensitivity to the constituents of Neupogen®, filgrastim (acetate, polysorbate 20, sodium and sorbitol) or hypersensitivity to Escherichia. Coli derived proteins. 8. 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. 9. 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. 10. Unable to follow protocol instructions in the opinion of the Investigator. 11. Donation or loss of 470 mL or more of blood over a period of 90 days prior to first IMP administration. 12. Positive screen for alcohol breath test and/or positive screen for drugs of abuse (opiates, methadone, methamphetamines, phencyclidine, tetrahydrocannabinol, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants,) at screening and admission (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 screening or on 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). 13. History of alcohol abuse or excessive intake of alcohol in the past 2 years as judged by the Investigator. 14. Positive screen on hepatitis B surface antigen (HbsAg), hepatitis B core antibody, anti hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) ½ antibodies at screening. 15. Family history of acute myeloid leukemia or subjects with splenomegaly (spleen size >13 cm in the craniocaudal dimension by ultrasound) at baseline, or with sickle cell disease. 16. Involvement with any CURATEQ BIOLOGICS PRIVATE LIMITED, Contract Research Organization (CRO) or study center employee or their close relatives.
Outcome results
None listed