HyperuricemiaPhase 1NCT05226013
Tolerance, Pharmacokinetics / Pharmacodynamics (PK / PD) and Immunogenicity of Pegylated Uric Acid Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers
A Phase 1 study testing Polyglycol lated urate oxidase for injection in people with Hyperuricemia, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- Polyglycol lated urate oxidase for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2021to 1 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Yu Cao, Doctor, +86-18661809090, caoyu1767@126.com
About this study
Official title: 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
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
- Being tested
- Polyglycol lated urate oxidase for injection, Placebo
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyglycol lated urate oxidase for injectionDrug
Single dose escalation
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Polyglycol lated urate oxidase for injection |
| Placebo | Placebo comparator | Placebo , specification: 5mg,Single dose. Groups received the placebo in 2 patients per group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 500 days
Maximum tolerated dose Maximum tolerated dose
Maximum tolerated dose Maximum tolerated dose for a single dose
Measured: 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
Measured: 500 days
Secondary outcomes (2)
Occurrence rate of Adverse Events
Adverse events were recorded to evaluate the safety of the studied drugs
Measured: 500 day
Immunogenicity
Antidrug antibody detection
Measured: 500day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start8 Dec 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Cao, Doctor, Principal investigator, The Affiliated Hospital of Qingdao UniversityChanggui Li, Doctor, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226013
- Sponsor's protocol ID
- XZ-PEG-UOX-001
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the technical achievements and outcomes of this trial are owned by Revised Biomedical (Hangzhou) Research Institute Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor.
Publications
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.
PubMed 40557749Sun 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.
PubMed 38164417
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05226013
- Acronym / sponsor ID
- XZ-PEG-UOX-001
- Conditions
- Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEGylated Urate Oxidase for Injection | Experimental | Drug: Polyglycol lated urate oxidase for injectionPEGylated 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo , specification: 5mg,Single dose. Groups received the placebo in 2 patients per group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Healthy volunteers:
- 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.
Key exclusion criteria (28 listed)
- Healthy volunteers:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyglycol lated urate oxidase for injectionSingle dose escalation | Drug | PEGylated Urate Oxidase for Injection |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 500 days
Evaluation of Peak Plasma Concentration (Cmax)
Maximum tolerated dose Maximum tolerated dose
Time frame: 500 days
Maximum tolerated dose Maximum tolerated dose for a single dose
Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 500 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
2 secondary outcomes
Occurrence rate of Adverse Events
Time frame: 500 day
Immunogenicity
Time frame: 500day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Derived from this study: PubMed 40557749Sun 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.
- Derived from this study: PubMed 38164417Sun 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.
- Individual participant dataSharing planned: No. All the technical achievements and outcomes of this trial are owned by Revised Biomedical (Hangzhou) Research Institute Co., Ltd. and the research center. The research center can not publish any academic papers without the consent of the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Cao, Doctor principal investigator
The Affiliated Hospital of Qingdao University
Changgui Li, Doctor principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polyglycol lated urate oxidase for injection in people with Hyperuricemia, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao, Doctor (+86-18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 500 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05226013, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.