None listed
Conditions
Interventions
Intervention1: Fulphila (Pegfilgrastim): a single 6 mg subcutaneous dose of Fulphila On Body injector (OBI) kit
Control Intervention1: Fulphila (Pegfilgrastim): a single 6 mg subcutaneous dose of Fulp
Sponsors
Biocon Biologics UK PLC
Syngene International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult male subjects within the age range of 18 to 65 years (both inclusive). 2. Weight not less than 45 kg. 3. Body mass index within range of 18.50 to 30.00 kg/m2 (both inclusive). 4. Capable and amenable to provide written informed consent to the study requirements. 5. Should not suffer from the significant diseases or clinically significant abnormal findings at the time of screening, based on medical history, physical examination, vital signs, 12 lead ECG and Chest X-ray (PA view, valid if it taken within 6 months prior to screening or if clinically indicated at the time of screening). 6. Non-smoker [defined as someone who has stopped smoking for a year before the date of screening] or light smoker, i.e., smokes maximum of 5 cigarettes (or 3 cigars or 3 pipes or other equivalents) per day; and ability and willingness to refrain from smoking from admission on Day -2 to till Day 5 of each period. 7. Subjects should be non-alcoholic and should have ability and willingness to abstain from alcohol from 48 hours prior to each admission to the clinical site and prior to ambulatory visits, and during the stays in the clinic. 8. Subjects should have ANC, total WBC count results within the reference ranges and platelet count, haemoglobin results within the acceptable ranges. 9. All other values for hematology and for clinical chemistry tests of blood and urine within the acceptable range or showing no clinically significant abnormality as judged by the Principal Investigator (PI)/Clinical Investigator (CI). 10. Negative screening of HIV 1 & 2, Hepatitis B surface antigen (HBsAg), anti-Hepatitis C virus (HCV) antibodies and RPR test for Syphilis. 11. Male subjects must be using two acceptable methods of contraception (e.g., spermicidal gel plus condom) for the entire duration of the study, and for at least three months after the last study drug administration. Subjects must refrain from fathering a child or donate sperm in the next three months following the last study drug administration or have undergone vasectomy (vasectomy must have been done more than 6 months prior to first dosing). Contraceptive usage requirements will be conveyed during the informed consent process.
Exclusion criteria
Exclusion criteria: Subjects fulfilling any of the following criteria will not be considered for inclusion into this study. 1. History or presence of cancer, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine (including diabetes), hematological, dermatological, venereal, neurological disorders, psychiatric diseases or other major disorders. 2. History or presence of significant: Asthma, urticaria or other allergic type reactions after taking Pegfilgrastim or any other drug Ulceration or history of gastric and/or duodenal ulcer or perforation Stomach or intestinal bleeding Jaundice in the past 6 months Any past or concurrent medical conditions that potentially increase the subject s risks or affect the evaluation of any study results. Examples of these include medical history with evidence of clinically relevant pathology (e.g., sickle cell disorders, spleen pathologies, hematologic malignancies or myelodysplastic disorders, and pulmonary illnesses such as acute respiratory distress syndrome [ARDS], interstitial pneumonia, pulmonary edema, pulmonary infiltrates, and pulmonary fibrosis) and history of relevant drug and/or food allergies. 3. Hypersensitivity or allergy to Pegfilgrastim or to any of the excipients of study drug product or acrylic adhesives or hypersensitivity to E. coli derived proteins. 4. Known history of previous exposure to filgrastim, pegfilgrastim, granulocyte colony stimulating factor (GCSF) or any analogue of these. 5. Symptoms and/or signs of any infection identified by history and physical examination within 1 week prior to first study drug administration. 6. Fructose intolerance. 7. First degree relatives with hematological malignancy. 8. Family history of bleeding disorders. 9. Presence of dermatological abnormalities at the injection site before dosing. 10. Have donated or lost more than or equal to 500 mL of blood over a period of 84 days prior (12 weeks) to study drug administration. Have donated or lost more than or equal to 500 mL of blood in the 12 months before study screening. 11. Subjects who have participated in another clinical study of an investigational drug within five times the half-life of the investigational product or the approved drug. 12. Any difficulty in accessibility of forearm veins for cannulation or blood sampling and or difficulty with donating blood. 13. History of alcohol or drug abuse (including soft drugs like cannabis products). 14. Found positive in breath alcohol test done prior to study check-in. 15. Inability to abstain from alcohol till the end of study [Regular intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirit)]. 16. Found positive in urine drug screening test [opiates, methadone, cocaine, amphetamines [including ecstasy], marijuana (THC), barbiturates, benzodiazepines and tricyclic antidepressants)] done prior to check-in of each study period. 17. Received any non-topical medications including over-the-counter products and herbal remedies such as St. John s Wort extract) within 5 days prior to first admission to the clinical site, with the exception of hormonal contraceptives, multivitamins, vitamin C, food supplements and a labelled amount of paracetamol (acetaminophen). 18. Unable to follow prot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve for pegylated-granulocyte colony-stimulating factor (PEG-GCSF) up to infinity (AUC0-inf). Maximum observed serum concentration of PEG-GCSF (Cmax) Timepoint: Day 15 of each period Day 15 of each period | — |
Secondary
| Measure | Time frame |
|---|---|
| PK: AUC0-t, z, tmax, t , CL/F, Vd/F and AUC%extrap Timepoint: Week 16;PD: Area under the ANC above baseline values versus time curve (ANC AUC0-t) (time 0 to time of last data collection point). Maximum change from baseline for ANC (ANC Cmax) The time of maximum change from baseline for ANC (ANC tmax). Timepoint: Week 16;Safety: AEs including ADRs, local tolerability at the injection site, abnormal and clinically significant vital signs, ECG, clinical laboratory parameters and abnormal & clinically significant physical examination findings. Timepoint: Week 16 | — |
Countries
India
Contacts
Public ContactDr Jayanti Panda
Biocon Biologics
Outcome results
None listed