Pharmacokinetics & pharmacodynamic ofBP14 (Pegfilgrastim) 6 mg/0.6 mL solution for Injection with that of‘Neulasta’ (Pegfilgrastim) 6 mg/0.6 mL solution for Injectio
- Registration Number
- CTRI/2023/06/054223
- Lead Sponsor
- CuraTeQ Biologics Private Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 184
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Pharmacokinetic parameters: Cmax & AUC0-t <br/ ><br>Timepoint: pre-dose (0.0 hour) & at 2.0, 4.0, 6.0, 8.0, 10.0, 12.0, 14.0, <br/ ><br>16.0, 18.0, 24.0, 32.0, 40.0, 48.0, 60.0, 72.0 (Day 3), 96.0 (Day 4), 120.0 <br/ ><br>(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 Outcome Measures
Name Time Method Immunogenicity : <br/ ><br>Percentage of subjects who develop detectable Anti-drug Antibodies (ADA) & Neutralizing antibodies <br/ ><br>Timepoint: pre-dose (0.0 hour), at 24.0 (Day 1) & 480.0 (Day 20) hours post dose;Pharmacodynamic parameters : <br/ ><br>Absolute neutrophil count: peak effect (Emax), Area under the effect curve AUEC0-t <br/ ><br>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 <br/ ><br>(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 <br/ ><br>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 <br/ ><br>(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