Tolerance, Pharmacokinetics / Pharmacodynamics (PK / PD) and Immunogenicity of Pegylated Uric Acid Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Affiliated Hospital of Qingdao University
• Treatments: Rasburicase

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.