None listed
Conditions
Interventions
Intervention1: INTP1
Active content: Filgrastim: Dose for administration: 5 mcg/kg
Manufacturer: Intas Pharmaceuticals Ltd., India
Pharmaceutical form: Pre-filled syringe
Route of administration: Subcutaneous
Control Intervention1: Neupogen® (Filgrastim) (US Licensed product) injection
Active content: Filgrastim,: Dose for administration: 5 mcg/kg
Marketing Authorization Holder: Amgen Inc., Thousand Oaks, California, USA
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Non-smoker, normal, healthy adult human volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India. 2 Having body weight greater than equal to 50 kg and body mass index (BMI) between 18.5 and 29.9 (both inclusive), calculated as weight in kg/ height in meter2. 3 Not having any significant disease in medical history or clinically significant abnormal findings during screening, abdominal ultrasonography, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view; within the last 6 months) recordings. 4 Able to understand and comply with the study procedures, in the opinion of the investigator. 5 Able to give voluntary written informed consent for participation in the trial. 6 In case of female subjects: a Surgically sterilized at least 6 months prior to study participation; Or If a woman of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study. b Serum pregnancy test (for female subjects) must be negative
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the study drug or its constituents and/or hypersensitivity to E. coli-derived proteins, and/or previous exposure to the study drug 2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system. 3. Known case of hereditary fructose intolerance 4. Subjects with latex allergies will be excluded as the needle cover on the single-use prefilled syringe contains dry natural rubber (latex). 5. Any clinically significant laboratory finding including ANC, platelet, RBC count or hemoglobin level at the time of screening. i. ANC (absolute neutrophil count) less than 2000/ cubic mm ii. Platelet less than 150,000/ cubic mm iii. Hemoglobin level less than 11.1 g/dL for male and less than 10.0 g/dL for female iv. RBC count less than 3.8 X 1000000/microlitre for female subjects and less than 4.5 X 1000000/ microlitre for male subjects at the time of screening. 6. Prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or pegfililgrastim; Prior exposure to vaccines, immunoglobulin preparations, or immunomodulator within the past 6 months prior to receiving the first dose; historical evidence of E coli diarrhea or diseases within 3 months. 7. QTc interval more than 450 ms on ECG measurement at the time of screening. 8. Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs-induced urticaria. 9. Subjects with a history of pulmonary infiltrate or pneumonia in the last 6 months. 10. History of any hematologic disease including sickle cell disorders. 11. Smokers, or who have smoked within last six months prior to start of the study. 12. Ingestion or use of any prescribed medication at any time within 1 month prior to receiving first dose in period I. 13. Receipt of over-the-counter medicines which have not yet cleared from the body (5 half-lives must have passed for the medicine to be considered to have cleared from the body). 14. A recent history of harmful use of alcohol, i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40 percent distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 72 hours prior to first dose administration of period-I. 15. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans. 16. Donation of blood (1 unit or 350 mL) or receipt of an investigational drug or product, or participation in a drug research study within six months prior to receiving the first dose of study medicine 17. Positive result for human immunodeficiency virus (HIV I and/or II) and/or hepatitis B and C tests. 18. History or presence of cancer because of which anticipated life span is less than 5 years as per the investigators assessment. 19. History or presence of psychiatric disorders. 20. Presence of tattoo or scars or any type of skin lesions due to infection, burning, wound or inflammation at the proposed site of injection. 21. An unusual die
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the multiple dose pharmacodynamics (CD34) of INTP1 with US approved Neupogen in normal healthy volunteersTimepoint: A total 10 blood samples for PD evaluation at pre-dose and at 24, 48, 72 and 96 before dosing. Additional samples at 120, 144, 168, 192 and 216 hours in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety (including immunogenicity) and PK of INTP1 with US approved Neupogen in normal healthy volunteersTimepoint: A total of 21 blood samples will be collected for PK and 05 blood sample of immunogenicity evaluation. For PK evaluation pre dose at 0.0, Day 01, 02, 03, 04 and 05; Post dose samples at 0.25, 0.5, 0.75, 1.0, 1.3, 1.6, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0 and 24.0 hours. For Immunogenicity evaluation at pre-dose of the first dose and at Day 12 and Day 33 in each period Sample on Day 33 in of period-I will be consider as pre-dose of period-II for Immunogenicity. | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed