tolerance, pharmacokinetics / pharmacodynamics (pk / pd) and immunogenicity of pegylated uric acid oxidase for injection in healthy adults and hyperuricemia volunteers

Conditions: Hyperuricemia

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.