NCT03786289已完成1 期
Single Administration of Recombinant Human Serum Albumin/Erythropoietin Fusion Protein for Injection, Tolerance, Safety, Pharmacokinetics and Pharmacodynamic Clinical Trials of Increased Dosage
Tianjin SinoBiotech Ltd.1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年12月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
The purpose of the study was to evaluate the safety of rHSA/EPO to healthy subjects and to investigate the pharmacokinetic characteristics of rHSA/EPO in healthy subjects, and to obtain preliminary pharmacokinetic parameters.
详细描述
This experiment was a single-center clinical study with randomized, open, positive drug control and single dose increment. The test group will be conducted in the order of incremental dose from 150μg to 1200μg 5 dose groups, with 1 positive control groups (EPIAO). After 7 days of administration, the researchers looked at the drug safety tolerance of the test to determine whether to proceed with the next higher dose group test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) in the range of 19.0~26.0 (including critical value) (bmi= bw (kg)/ Height 2 (m2), male weight should be ≥50kg, female weight should be ≥45kg
- •Understand and sign the informed consent form
排除标准
- •Persons with allergic physique or sensitive skin;
- •Any person with any skin disease;
- •have a history of drug or food allergies, especially for the active ingredients of this product or similar drugs, mammalian cells to The source of the drug, human serum albumin or other biological agents expressed in CHO allergy;
- •Pre-Test medical history, vital signs, physical examination, laboratory examination and other relevant examinations during the screening period, Abnormal and clinically significant person;
- •Previous intentional cerebral vessels, liver, kidneys, lungs, digestive tract, nerves, autoimmune, metabolic and skeletal muscle system, hematopoietic system and other diseases of history;
- •Having a fertility plan within 2 weeks of screening and within 6 months of the end of the trial and not having to take it during the trial period
- •(a) Effective non-drug contraceptive measures;
- •Within 14 days prior to screening or within 5 half-life of the drug (whichever is the oldest of the two) there has been any Prescription drugs, over-the-counter drugs, Chinese herbal medicine, health care products medicine history;
- •Hemoglobin ≤130 g/L or ≥150/g (male), hemoglobin ≤115 g/L or ≥133 g/L (female version number: 1.2 Version date: September 30, 2018 26 sexual);
- •The percentage of erythrocyte red blood cells ≥ 3%;
- •ferritin <200 ng/ml (male), ferritin <80 ng/ml (female);
- •The use of drugs known to have damage to an organ during the first 3 months of screening;
- •A person who has received a blood transfusion or rhEPO treatment;
- •Clinically determined to be vitamin B12 or folic acid deficiency;
- •Have a history of dizziness and needle sickness;
- •A clinical trial person who has participated in other drugs within the first 3 months of screening;
- •Those who had lost blood or blood ≥200ml during the first 8 weeks of screening;
- •Women during pregnancy and lactation;
- •The researchers did not consider it appropriate to enter the trial.
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Day1-Day29
Incidence of adverse events, adverse reactions and serious adverse events after single administration
次要结局
- Erythrocyte count,before and after administration(Day1-Day29)
- hemoglobin,before and after administration(Day1-Day29)
- Concentration of recombinant human serum albumin/erythrocyte fusion protein in serum(Day1-Day29)
- Concentration of recombinant human erythropoietin injection (Cho cell) in serum(Day1-Day29)
- the percentage of erythrocyte red blood cells,before and after administration(Day1-Day29)
- erythrocyte ratio (HCT) before and after administration(Day1-Day29)
研究者
研究点 (1)
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