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Hyperuricemia

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

Sponsored by The Affiliated Hospital of Qingdao University

About this trial

Last updated 4 years ago

Study ID

XZ-PEG-UOX-001

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

18-75 Years
18 to 60 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status

Recruiting