NCT05226013Unknown1 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerance, Pharmacokinetics / Pharmacodynamics (PK / PD) and Immunogenicity of Pegylated Uric Acid Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose Maximum tolerated dose
研究概览
简要总结
A randomized, double-blind, placebo-controlled study of tolerance, pharmacokinetic / pharmacodynamics (PK / PD) and immunogenicity of single administration of PEG uric oxidase for injection in healthy adults and hyperuricemia volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy volunteers:
- •Subjects understand well trial purpose, nature, content, process and possible adverse reactions, and voluntarily sign an informed consent form.
- •Serum uric acid level<360 µ mol / L twice on different days.
- •Healthy male or female aged between 18 and 60 years old (including the critical value).
- •The body mass index is in the range of 18-30kg/m2 (including the critical value). The weight of male is not less than 50 kg, and that of female is not less than 45 kg (including the critical value).
- •Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous, haemal diseases or hepatic/renal impairment.The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: physical examination, 12-lead ECG, vital sign measurements and laboratory safety tests .
- •The subjects have no family planning within 6 months and could select contraceptive method. They have no sperm and egg donation program.
- •Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
- •The blood pregnancy test of female subjects was negative, the menstrual cycle was regular, and the menstrual bleeding period was 3 ~ 7 days.
- •Patients with hyperuricemia:
- •Patients with hyperuricemia ,male or female aged between 18 and 60 years old (including the critical value).
- •Stop uric acid lowering treatment for at least 7 days, and 480≤UA≤540µmol/L twice on different days within 7 days.
- •The body mass index is in the range of 18-30kg/m2 (including the critical value). The weight of male is not less than 50 kg, and that of female is not less than 45 kg (including the critical value).
- •Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
- •The blood pregnancy test of female subjects was negative, the menstrual cycle was regular, and the menstrual bleeding period was 3 ~ 7 days.
排除标准
- •Healthy volunteers:
- •A history of drug allergy, or allergic allergic disease, or known to be allergic to the test drug or its excipients or the same type of drug;
- •Hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;
- •Any history of acute or chronic illness that might affect drug absorption, and/or metabolism;
- •Any history of drug abuse in the past 12 months prior to screening;
- •Any history of alcohol abuse 3 months prior to screening or moderate drinkers (drink more 2 units per day or 14 units per week);
- •Smoking more than 5 cigarettes per day during the 3 months prior to screening;
- •Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening;
- •Any use of other prescription drugs (including contraceptive)#over-the counter drugs, Chinese herbal medicine, health care products and 14 days prior to medication for this study;
- •Any history of postural hypotension, syncope, or amaurosis;
- •6-glucose phosphate dehydrogenase (G6PD) deficiency;
- •Lactating or pregnant women
- •Patients with hyperuricemia:
- •Using uric acid lowering drugs and unwilling to stop existing drugs.
- •Ultrasonic examination of the metatarsal-toe joint suggested the presence of tophi.
- •Serum CA72-4 level ≥7.5U / mL.
- •History of organic heart disease (symptomatic cardiac insufficiency with grade II-IV).
- •Patients with refractory hypertension.
- •Patients with malignant tumors (treatment or not).
- •Patients with organ transplantation treated with immunosuppressants.
- •Any history of drug abuse in the past 12 months prior to screening;
- •Any history of alcohol abuse 3 months prior to screening or moderate drinkers (drink more 2 units per day or 14 units per week).
- •Smoking more than 5 cigarettes per day during the 3 months prior to screening.
- •A history of drug allergy, or allergic allergic disease, or known to be allergic to the test drug or its excipients or the same type of drug.
- •Any history of acute or chronic illness that might affect drug absorption, and/or metabolism.
- •6-glucose phosphate dehydrogenase (G6PD) deficiency.
- •Once treated with urate oxidase.
- •Subjects had an uncorrected dehydration, acidosis, hypotension, renal insufficiency, or were using drugs with nephrotoxicity.
研究组 & 干预措施
PEGylated Urate Oxidase for Injection
Experimental
PEGylated Urate Oxidase for Injection，specification:5mg，Single dose ascending.Healthy subjects were divided into three dose groups (0.5mg, 1mg, 2mg), and hyperuricemia patients were divided into four dose groups (2mg, 4mg, 8mg, 12 mg), with increasing dose design.Each group will receive the experimental drug in 6 subjects.
干预措施: Polyglycol lated urate oxidase for injection (Drug)
Placebo
Placebo Comparator
Placebo , specification: 5mg,Single dose. Groups received the placebo in 2 patients per group.
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum tolerated dose Maximum tolerated dose
时间窗: 500 days
Maximum tolerated dose Maximum tolerated dose for a single dose
Peak Plasma Concentration (Cmax)
时间窗: 500 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
时间窗: 500 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
次要结局
- Occurrence rate of Adverse Events(500 day)
- Immunogenicity(500day)
研究者
研究点 (1)
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