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

NCT05226013 | Unknown Phase 1 DMC

• 1 other identifier: XZ-PEG-UOX-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  500 days

• Maximum tolerated dose Maximum tolerated dose

  Maximum tolerated dose Maximum tolerated dose for a single dose

  500 days

• Area under the plasma concentration versus time curve (AUC)0-t

  Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

  500 days

Secondary Outcomes (2)

• Occurrence rate of Adverse Events

  500 day

• Immunogenicity

  500day

Study Arms (2)

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.

Drug: Polyglycol lated urate oxidase for injection

Placebo

PLACEBO COMPARATOR

Placebo , specification: 5mg,Single dose. Groups received the placebo in 2 patients per group.

Drug: Placebo

Interventions

Polyglycol lated urate oxidase for injection DRUG

Single dose escalation

PEGylated Urate Oxidase for Injection

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

Related Publications (2)

• Sun F, Zhang J, Yan Z, Yu Q, Wang P, He Y, Liu M, Huang B, Fang L, Xu Y, Fu Y, Gao X, Li C, Cao Y. Efficacy and safety of PEGylated uricase in healthy adults and patients with hyperuricaemia: A phase I, randomized, double-blind, dose-escalation, placebo-controlled trial. Diabetes Obes Metab. 2025 Sep;27(9):4892-4902. doi: 10.1111/dom.16532. Epub 2025 Jun 25.

  PMID: 40557749 DERIVED

• Sun F, Wang C, Xu Y, Lin P, Cao Y, Zhang J, Li X, Jiang X, Fu Y, Cao Y. Randomized, Double-Blind, Placebo-Controlled, Phase I, Dose- Escalation Study to Evaluate the Tolerance, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PEGylated Urate Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers: Study Protocol. Diabetes Metab Syndr Obes. 2023 Dec 28;16:4263-4268. doi: 10.2147/DMSO.S429114. eCollection 2023.

  PMID: 38164417 DERIVED

MeSH Terms

Conditions

Hyperuricemia

Interventions

Injections

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yu Cao, Doctor

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

• Changgui Li, Doctor

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Cao, Doctor

CONTACT

+86-18661809090; caoyu1767@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 7, 2022
• Study Start: December 8, 2021
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)