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

The Affiliated Hospital of Qingdao University1 site in 1 country54 target enrollmentDecember 8, 2021

ConditionsHyperuricemia

InterventionsPolyglycol lated urate oxidase for injection Placebo

DrugsPolyglycol lated urate oxidase for injection Placebo

Overview

Phase: Phase 1
Intervention: Polyglycol lated urate oxidase for injection
Conditions: Hyperuricemia
Sponsor: The Affiliated Hospital of Qingdao University
Enrollment: 54
Locations: 1
Primary Endpoint: Maximum tolerated dose Maximum tolerated dose
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 8, 2021

End Date

April 1, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

The Affiliated Hospital of Qingdao University

Responsible Party

Sponsor

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:

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;

Arms & Interventions

PEGylated Urate Oxidase for Injection

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.

Intervention: Polyglycol lated urate oxidase for injection