A Randomized, Balalnced, Open-label, Two-treatment, Two-period,Two sequence, Single dose, Crossover, Comparative bioavailability study of INTP5 Pegfilgrastim of Intas Pharmaceuticals Limited, India when delivered automatically from the on body injector (OBI) delivery device (test product) versus INTP5 (ENNUMOTM) PFS, when delivered manually from a pre-filled syringe (reference product) in normal, healthy, adult, human subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- To assess comparative bioavailability of INTP5 (Pegfilgrastim) (Delivered automatically from the
研究概览
简要总结
Primary objective: To assess comparative bioavailability of INTP5 (Pegfilgrastim) (delivered automatically from the on-body injector delivery device) versus INTP5 (ENNUMOTM) PFS in normal, healthy, adult, human subjects.
Secondary objectives: To assess and compare other pharmacokinetic parameters, safety and tolerability of INTP5 (Pegfilgrastim) (delivered automatically from the on-body injector delivery device) versus INTP5 (ENNUMOTM) PFS in normal, healthy, adult, human subjects and to monitor the performance of on-body injector delivery device in normal, healthy, adult, human subjects (as per annex-I).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Non-smoking, normal, healthy, adult, human volunteers between 18 and 45 years of age (both inclusive).
- •Having body weight greater than or equal to 50 kg and body mass index (BMI) between 18.5 and 29.9 (both inclusive), calculated as weight in kg per height in meter
- •Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12-lead ECG, Xray chest (P A view; within the last 6 months) and abdominal ultrasonography 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: 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 must be negative.
排除标准
- •Known hypersensitivity or idiosyncratic reaction 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.
- •No medication [prescribed & over the counter (OTC) medication] other than the IMP shall be consumed by the subjects from 1 month prior to check-in of period-I.
- •Other than paracetamol or NSAIDs for pain and vitamins, minerals and nutritional supplements that may be taken at the discretion of the Investigator and any vaccine (including COVID-19 vaccine) from 14 days prior to check-in of period-I.
- •In any such case subject selection will be at the discretion of the Principal Investigator designee.
- •Known case of hereditary fructose intolerance 5) 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 ANC, platelet, RBC count or hemoglobin level at the time of screening.
- •Consumption or use of any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or Pegfilgrastim, immunoglobulin preparations, or immunomodulator’s within the past 6 months Prior to dosing of period-I.
- •Historical evidence of E coli diarrhea or diseases within 3 months.
- •Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDsinduced urticaria.
- •Subjects with a history of pulmonary infiltrate or pneumonia in the last 6 months.
- •History of any hematologic disease including sickle cell disorders.
- •Smokers, or who have smoked within last six months prior to start of the study.
- •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 (less than 2 years), 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 percentage distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 72 hours prior to check-in of period-I.
- •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) within a period of 90 days prior to the first dose of study medication.
- •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.
- •If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- •A positive hepatitis screen including hepatitis B surface antigen and or HCV antibodies.
- •A positive test result for HIV (1 and or 2) antibody.
- •History or presence of seizure or 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 check-in of period-I.
- •Consumption of grape fruit or grape fruit products within 72 hours prior to check-in of period-I.
- •A history of difficulty in donating blood.
- •Females, pregnant or lactating, or planning to become pregnant during the course of the study or found positive in pregnancy test at screening.
- •Any infections in the last 4 weeks prior to dose administration of period-I.
结局指标
主要结局
To assess comparative bioavailability of INTP5 (Pegfilgrastim) (Delivered automatically from the
时间窗: Time points for OBI: | 1) 0.000 (Pre-dose) (Collected within 60 minutes prior to start of drug delivery) | 2) At 1, 10, 20 and 30 min After the start of drug delivery | 3) Approx. 40 min (i.e. at the end of drug delivery) (Reference timepoint for post-dose sampling timepoints) | 4) From end of drug delivery at 0.167, 0.333, 0.500, 1.000, 2.000, 3.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 18.000, 20.000, 22.000, 24.000, 27.000, 30.000, 36.000, 48.000, 60.000, 72.000, 96.000, 120.000, 168.000, 216.000, 264.000, 312.000 hours post-dose. | Time points for PFS: | Pre-dose (0.000) (i.e. Sample | within 60 minutes prior to dosing) and at 0.167, 0.333, 0.500, 1.000, 2.000, 3.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 18.000, 20.000, 22.000, 24.000, 27.000, 30.000, 36.000, 48.000, 60.000, 72.000, 96.000, 120.000, | 168.000, 216.000, 264.000, 312.000 hours post-dose.
on-body injector delivery device) versus INTP5 (ENNUMOTM) PFS in normal, healthy, adult,
时间窗: Time points for OBI: | 1) 0.000 (Pre-dose) (Collected within 60 minutes prior to start of drug delivery) | 2) At 1, 10, 20 and 30 min After the start of drug delivery | 3) Approx. 40 min (i.e. at the end of drug delivery) (Reference timepoint for post-dose sampling timepoints) | 4) From end of drug delivery at 0.167, 0.333, 0.500, 1.000, 2.000, 3.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 18.000, 20.000, 22.000, 24.000, 27.000, 30.000, 36.000, 48.000, 60.000, 72.000, 96.000, 120.000, 168.000, 216.000, 264.000, 312.000 hours post-dose. | Time points for PFS: | Pre-dose (0.000) (i.e. Sample | within 60 minutes prior to dosing) and at 0.167, 0.333, 0.500, 1.000, 2.000, 3.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 18.000, 20.000, 22.000, 24.000, 27.000, 30.000, 36.000, 48.000, 60.000, 72.000, 96.000, 120.000, | 168.000, 216.000, 264.000, 312.000 hours post-dose.
human subjects.
时间窗: Time points for OBI: | 1) 0.000 (Pre-dose) (Collected within 60 minutes prior to start of drug delivery) | 2) At 1, 10, 20 and 30 min After the start of drug delivery | 3) Approx. 40 min (i.e. at the end of drug delivery) (Reference timepoint for post-dose sampling timepoints) | 4) From end of drug delivery at 0.167, 0.333, 0.500, 1.000, 2.000, 3.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 18.000, 20.000, 22.000, 24.000, 27.000, 30.000, 36.000, 48.000, 60.000, 72.000, 96.000, 120.000, 168.000, 216.000, 264.000, 312.000 hours post-dose. | Time points for PFS: | Pre-dose (0.000) (i.e. Sample | within 60 minutes prior to dosing) and at 0.167, 0.333, 0.500, 1.000, 2.000, 3.000, 6.000, 8.000, 10.000, 12.000, 14.000, 16.000, 18.000, 20.000, 22.000, 24.000, 27.000, 30.000, 36.000, 48.000, 60.000, 72.000, 96.000, 120.000, | 168.000, 216.000, 264.000, 312.000 hours post-dose.
次要结局
- 1) To assess and compare other pharmacokinetic parameters, safety and(tolerability of INTP5 (Pegfilgrastim) (delivered automatically from the on-body injector delivery device) versus INTP5 (ENNUMOTM) PFS in normal, healthy, adult, human subjects.)
研究者
Dr Shrikrishna Kolte
Lambda Therapeutic Research Ltd