Status:
COMPLETED
Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
Lead Sponsor:
Intas Pharmaceuticals, Ltd.
Collaborating Sponsors:
Lambda Therapeutic Research Ltd.
Conditions:
Immunogenicity
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Intas Phar...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Normal, healthy adult human volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- Having body weight ≥50 kg and body mass index (BMI) between 18.5 and 29.9 (both inclusive), calculated as weight in kg/height in meter\^2.
- 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 echocardiogram (ECG) and chest X-ray (posterior-anterior view; within the last 6 months) recordings.
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
- In case of female subjects:
- 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.
- Serum pregnancy test (for female subjects) must be negative.
- Exclusion criteria:
- 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.
- 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.
- Known case of hereditary fructose intolerance.
- Subjects with latex allergies will be excluded as the needle cover on the single-use prefilled syringe contains dry natural rubber (latex).
- Any clinically significant laboratory finding including absolute neutrophil count (ANC), platelet, red blood cells (RBC) count, and hemoglobin level at the time of screening.
- Prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or Pegfilgrastim; Prior exposure to any vaccines, immunoglobulin preparations or immunomodulators within the past 6 months prior to receiving first dose; evidence of E. coli diarrhea or diseases within 3 months.
- Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs induced urticaria.
- Subjects with a history of pulmonary infiltrate or pneumonia in the last 6 months.
- History of any hematologic disease including sickle cell disorders.
- Ingestion or use of any prescribed medication at any time within 1 month prior to receiving first dose.
- 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).
- 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% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 72 hours prior to receiving study medicine.
- Smokers, who smoke 10 or more than 10 cigarettes/day or inability to abstain from smoking during the study.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- Donation of blood (1 unit or 350 mL) or equivalent amount of blood substitute.
- Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- Positive result for human immunodeficiency virus (HIV I \&/or II) and/or hepatitis B and C tests.
- History or presence of cancer because of which anticipated life span is less than 5 years as per the investigator's assessment.
- History or presence of psychiatric disorders.
- Presence of tattoo or scars or any type of skin lesions due to infection, burning, wound or inflammation at the proposed site of injection.
- An unusual diet, for whatever reason (e.g. low-sodium), for 4 weeks prior to receiving the study medicine. In any such case, subject selection will be at the discretion of the Principal Investigator.
- Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug.
- A history of difficulty in donating blood.
- Females, pregnant or lactating, or planning to become pregnant during the time the subject is on study or found positive in pregnancy test at screening.
- Any infections in the last 4 weeks before receiving study medication.
Exclusion
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2018
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04015232
Start Date
February 26 2018
End Date
June 5 2018
Last Update
October 4 2019
Active Locations (1)
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1
Lambda Therapeutic Research Ltd.
Ahmedabad, Gota, India, 382481