CTRI/2025/01/078921已完成1 期
A randomized, observer blind, parallel-group, active controlled, single dose study to compare pharmacokinetic, pharmacodynamic, safety and immunogenicity of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) of Incepta and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection of Roche (Mircera) in healthy adult human subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To compare and evaluate the pharmacokinetics of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection (Mircera)
研究概览
简要总结
A randomized, observer blind, parallel-group, active controlled, single dose study to compare pharmacokinetic, pharmacodynamic, safety and immunogenicity of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) of Incepta and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection of Roche (Mircera) in healthy adult human subjects.
Objectives:
To compare and evaluate the pharmacokinetics & pharmacodynamic of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection (Mircera) administered through subcutaneous route in healthy adult human subjects.
To assess the safety and tolerability of the investigational products.
To assess the immunogenicity of the investigational products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
入选标准
- •Volunteers must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified.
- •Age: 18 to 55 years old, both inclusive.
- •Gender: Male and/or non-pregnant, non-lactating female.
- •Female of childbearing potential must have a negative serum beta human chorionic gonadotropin pregnancy test performed within 28 days prior to dosing day.
- •They must be using an acceptable form of contraception.
- •For female of childbearing potential, acceptable forms of contraception include the following: B.
- •Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii.
- •Barrier methods containing or used in conjunction with a spermicidal agent, or iii.
- •Surgical sterilization or iv.
- •Practicing sexual abstinence throughout the course of the study.
- •Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history: i.
- •Postmenopausal with spontaneous amenorrhea for at least one year, or ii.
- •Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iv.
- •Total hysterectomy and an absence of bleeding for at least 3 months.
- •BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
- •Volunteers having body weight not < 50 kg or > 90 kg.
- •Willing to provide written informed consent to participate in the study.
- •Hemoglobin should be between 11-14 g/dl, HCT, Platelet count, ferritin and reticulocyte count percentage should not be higher than the upper limit of normal range.
- •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 study medication administration which will include: a) A physical examination (clinical examination) with no clinically significant finding.
- •b) Results within normal limits or clinically non-significant • Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion.
- •• 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.
排除标准
- •Volunteers must not be enrolled in the study if they meet any one of the following criteria: 1) History of allergic responses to Pegylated Erythropoietin or other related drugs, or any of its formulation ingredients.
- •Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)].
- •Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, endocrine, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- •History or presence of bronchial asthma.
- •Use of any hormone replacement therapy within 3 months prior to study medication administration.
- •Use of any depot injection or implant of any drug within 3 months prior to study medication administration.
- •Use of CYP enzyme inhibitors or inducers within 30 days prior to study medication administration (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
- •History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- •Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
- •A positive hepatitis screen (includes subtypes B and C).
- •A positive test result for HIV antibody.
- •Volunteers who have received a known investigational drug within seven elimination half-life of the administered drug prior to study medication administration.
- •Volunteers who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or gather than 200 ml within 90 days (excluding volume drawn at screening for this study) prior to study medication administration, whichever is greater.
- •Intolerance to venipuncture 16) Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer’s participation in this study.
- •Institutionalized volunteers.
- •Use of any prescribed medications within 14 days prior to study medication administration.
- •Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to study medication administration.
- •Use of grapefruit and grapefruit containing products within 7 days prior to study medication administration.
- •Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), cigarettes and tobacco containing products, recreational drugs, alcohol or other alcohol containing products within 48 hours prior to study medication administration.
- •Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to study medication administration.
- •Acute bleeding and blood transfusion within 2 months before inclusion in the study.
- •History of chronic bleeding.
- •History of allergies (anaphylactic shock or multiple drug allergy syndrome).
- •Major surgery within 30 days prior to screening, or surgery being scheduled for any time during the study.
- •Diseases or other conditions that can interfere with the pharmacokinetics of the investigational drug (e.g. chronic liver, kidney, blood, circulatory system, lung or neuroendocrine diseases, including diabetes mellitus and others).
结局指标
主要结局
To compare and evaluate the pharmacokinetics of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection (Mircera)
时间窗: 7 weeks
次要结局
- To assess pharmacodynamics, the safety and tolerability and immunogenicity of the investigational products of Pegylated Erythropoietin 100 mcg/0.3 ml injection (PEG-EPO) and Methoxy Polyethylene Glycol-Epoetin Beta 100 micrograms/0.3 ml solution for injection (Mircera)
研究者
Dr Minesh Patel
Cliantha Research Limited
研究点 (1)
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