None listed
Conditions
Interventions
Intervention1: BP14 (Pegfilgrastim) 6 mg/0.6 mL solution for Injection: A single dose [6 mg i.e. 0.6 mL (10 mg/mL)] of test product BP14
(Pegfilgrastim) 6 mg/0.6 mL solution for Injection will be
admi
Sponsors
CuraTeQ Biologics Private Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Volunteers having body weight 50 kg or more and 100 kg and less. 2. Volunteers 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. 3. Able to communicate effectively with study personnel. 4.Willing to provide written informed consent to participate in the study. 5. 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 (Hematology,Biochemistry,Urinalysis andImmunological Tests) within normal limits or clinically non-significant. 6. Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion. 7. 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: 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. 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. 3. History or presence of bronchial asthma. 4. Use of any hormone replacement therapy within 3 months prior to the first dose of study medication. 5. Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication. 6. Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication 7. Volunteer having Total WBC count higher than the upper limit of normal range during screening. 8. Volunteer having Platelets counts lower than the lower limit of normal range during screening. 9. Volunteer having Serum creatinine and serum bilirubin higher than the upper limit of normal range during screening 10. Volunteer having SGPT, SGOT and Alkaline phosphatase higher than 1.1 times of upper limit of normal range during screening. 11. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Pharmacokinetic parameters: Cmax & AUC0-t Timepoint: pre-dose (0.0 hour) & at 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 14.0, 16.0, 18.0, 24.0, 32.0, 40.0, 48.0, 60.0, 72.0 (Day 3), 96.0 (Day 4), 120.0 (Day 5), 144.0 (Day 6), 168.0 (Day 7), 216.0 (Day 09), 264.0 (Day 11), 312.0 (Day 13) & 480.0 (Day 20) hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity : Percentage of subjects who develop detectable Anti-drug Antibodies (ADA) & Neutralizing antibodies Timepoint: pre-dose (0.0 hour), at 24.0 (Day 1) & 480.0 (Day 20) hours post dose;Pharmacodynamic parameters : Absolute neutrophil count: peak effect (Emax), Area under the effect curve AUEC0-t Timepoint: pre-dose (0.0 hour) & at 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 14.0,16.0, 18.0, 24.0, 32.0, 40.0, 48.0, 60.0, 72.0 (Day 3), 96.0 (Day 4), 120.0 (Day 5), 144.0 (Day 6), 168.0 (Day 7), 216.0 (Day 09), 264.0 (Day 11),312.0 (Day 13) and 480.0 (Day 20) hours post dose;Secondary Pharmacokinetic parameters: AUC0-inf, Tmax, Kel & t1/2 Timepoint: pre-dose (0.0 hour) & at 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 14.0,16.0, 18.0, 24.0, 32.0, 40.0, 48.0, 60.0, 72.0 (Day 3), 96.0 (Day 4), 120.0 (Day 5), 144.0 (Day 6), 168.0 (Day 7), 216.0 (Day 09), 264.0 (Day 11), 312.0 (Day 13) and 480.0 (Day 20) hours post dose | — |
Countries
India
Contacts
Public ContactDr Arpitkumar Prajapati
CuraTeQ Biologics Private Ltd
Outcome results
None listed