NCT04873765已完成1 期
Phase I Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Pegfilgrastim in Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Megalabs
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Evaluation of AUC 0-t of pegfilgrastim in healthy volunteers for test and reference
研究概览
简要总结
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP)
- •Males aged between 18 and 55 years
- •Be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ECG),
- •Not indicating any evidence of disease
- •Body weight between 60-100 kg;
- •Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 Kg / m2;
- •Negative test for coronavirus
排除标准
- •Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° C), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods);
- •Direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods);
- •Living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods).
- •Participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma;
- •Participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis;
- •Participants with chronic diseases and, therefore, who regularly use medications;
- •Being a smoker or quitting less than 6 months ago;
- •Participants who consume more than 5 cups of tea or coffee a day and who cannot abstain during the trial period;
- •History of alcohol and illicit drug abuse
- •Electrocardiogram (ECG) findings that, at the investigator's discretion, may compromise participation in the trial;
- •History or presence of gastrointestinal or liver diseases or any other condition that interferes with the absorption, distribution, excretion or metabolism of the drug;
- •Use of lithium 2 weeks before and / or after medication administration;
- •Participants who are hypersensitive or contraindicated to use any of the components of the formulation;
- •Research participants who have participated in clinical trial protocols in the last 12 (twelve) months (Resolution CNS 251, of August 7, 1997, item III, subitem J);
- •Have donated blood (> 500 mL) or have undergone major surgery in the 3 (three) months preceding the date of signing the informed consent form;
- •Have received any vaccine in the 3 (three) months preceding the date of signing the informed consent form;
结局指标
主要结局
Evaluation of AUC 0-t of pegfilgrastim in healthy volunteers for test and reference
时间窗: 16 days
Evaluation of Cmax in healthy volunteers for test and reference
时间窗: 16 days
Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference
时间窗: 16 days
次要结局
- Evaluation of CD34+ count for test and reference(6 days)
研究者
研究点 (2)
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