None listed
Conditions
Interventions
Intervention1: BP14 (Pegfilgrastim)
Injection 6 mg/0.6 mL
: 6 mg/0.6 mL (10 mg/mL) pre-filled syringe
Duration: Two doses
Control Intervention1: Neulasta Injection 6 mg/0.6 mL: 6 mg/0.6 mL (10 mg/
Sponsors
CuraTeQ Biologics Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5). 4) Volunteers having body weight 50 kg or more and 100 kg and less. 5) Volunteer is considered to be in good health, as determined by: a) The absence of clinically significant illness or surgery within 4 weeks prior to dosing b) The absence of a clinically significant history of disease. c) The absence of a clinically significant history of skin disorders, including psoriasis 6) Able to communicate effectively with study personnel. 7) Willing to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) 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 20, or sorbitol. 2) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording and ultrasonography abdomen]. 3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system. 4) History or presence of bronchial asthma. 5) Use of any hormone replacement therapy within 3 months prior to the first dose of study medication. 6) Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication. 7) Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication. 8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use. 9) Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period. 10) History of difficulty with donating blood or difficulty in accessibility of veins. 11) A positive hepatitis screen (includes subtypes B & C). 12) A positive test result for HIV antibody. 13) Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication. 14) Intolerance to venipuncture 15) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer s participation in this study. 16) Institutionalized volunteers. 17) Use of any prescribed medications within 14 days prior to the first dose of study medication. 18) Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication. 19) Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication. 20) 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 within 48 hours prior to the first dose of study medication. 21) Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication. 22) Volunteer with history of cancer. 30) 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. 23) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment emergent ADA incidence rate between BP14 (Pegfilgrastim) and US- Licensed Neulasta (Pegfilgrastim)Timepoint: from day 1 to day 58 | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: Incidence of anti-PEG antibodies, anti-G-CSF antibodiesTimepoint: from day 1 to day 58;Safety: TEAE, TESAEs, AESIs, Injection site reactions, clinical laboratory values, vital signs, physical examinations, & ECGTimepoint: throughout the study | — |
Countries
India
Contacts
Public ContactDr Arpitkumar Prajapati
CuraTeQ Biologics Private Ltd
Outcome results
None listed