NCT05226013

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Polyglycol lated urate oxidase for injection	Single dose escalation
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-12-08
• Primary completion: 2022-12-01
• Completion: 2023-04-01
• First posted: 2022-02-07
• Last updated: 2022-02-07

Locations

1 site across 1 country: China