Safety and Tolerance Study of Recombinant Human Albumin Injection in Healthy Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Safety and tolerance
研究概览
简要总结
A phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation study, and a positive-controlled multiple dose extension study to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy subjects
详细描述
This study was to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy volunteers. The safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection were evaluated in a single center, randomized, double-blind, placebo-controlled single dose incremental trial in healthy volunteers. The study was divided into two stages: the first stage was a single dose and dose increasing stage (including 5 dose groups with increasing dose, and each group was set with placebo control); the second stage was multiple administration stage (with positive control). The safety, tolerance, pharmacokinetics, immunogenicity and other early clinical data of recombinant human albumin were collected and analyzed in the two stages. The initial dose was 1.25g. The highest dose group was set at 30g. The dose groups of 1.25, 5, 10, 20 and 30 g / time were preset in the single dose stage (dose increasing stage). The dosage was 10 g / Day in multiple administration stage.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1）Informed consent form signed; 2) To be able to complete the study; 3) Subjects (including partners) are willing to take contraceptive measures; 4) 18-55 years of age; 5) Male subjects are no less than 50 kg.Female subjects are no less than 45 kg. Body mass index is 18-28kg / m2; 6) Normal cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 50%; 7) Physical examination and vital signs are normal.
排除标准
- •Cigarettes Smoking subjects.
- •Allergic constitution (multiple drugs and food allergies);
- •History of drug use and/or alcohol abuse;
- •Blood donation or massive blood loss (> 450 mL) within three months before screening;
- •Taking any drugs, prescription, over-the-counter, vitamin products or herbal medicine within 14 days before screening;
- •Diet or exercise have changed recently;
- •Using study drugs within three months;
- •Risk of bleeding, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
- •ECG abnormalities (QTc > 470ms for males, > 480ms for females);
- •Female subjects are in lactation. Pregnancy test is positive;
- •Other Clinical laboratory tests abnormalities;
- •Viral screening test is positive, including HBV, HCV, HIV, and Treponema pallidum;
- •Developing Acute disease;
- •Eating chocolate, any caffeine-containing or jaundice-rich food or drink 24 hours prior to the use of the study drug;
- •Taking any alcoholic products. Alcohol test is positive..
- •Drug test is positive. History of drug abuse or drug use in the past five years;
- •Inability for intravenous injection or blood collection;
- •Using biological products (including live vaccines) within the last 3 months. Planing to use vaccines during the study period. Having received corticosteroid or human plasma product system treatment within 1 month.
- •Renal function is abnormal, glomerular filtration rate <80 mL/min (according to the simplified MDRD formula);
- •History of glaucoma, eye disease.
- •History of cancer or other serious systemic diseases, especially heart, liver, kidney, digestive tract, nervous system, metabolic abnormalities, immune abnormalities or mental disorders;
- •History of immunodeficiency or hypofunction;
- •Received major surgery within 2 years.
- •Other subjects by investigator opinion..
研究组 & 干预措施
Control: placebo
Subjects received 0.9% sodium chloride injection.
干预措施: Placebo (Drug)
Control: Human Serum Albumin(HSA)
Subjects received Human Serum Albumin, 10 g for each day, three days for a cycle, and totally three cycles.
干预措施: human albumin injection (Drug)
Experimental:recombinant human albumin
Subjects received recombinant Human Serum Albumin, 1.25g, 5g, 10g, 20g, 30 g for the single dose study. For the multiple dose study, subjects received recombinant Human Serum Albumin, 10 g for each day, three days for a cycle, and totally three cycles.
干预措施: recombinant human albumin injection (Drug)
结局指标
主要结局
Safety and tolerance
时间窗: Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.
AE
次要结局
- PK parameters(Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.)
- Pharmacodynamic parameters(Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.)
- Immunogenicity(Day 1-Day 57 for single doses study. Day 1-Day 106 for multiple doses study.)