Gout Clinical Trial
Official title:
A Cohort Dose-Escalation Phase 1 Study of Intramuscular Injection of Uricase-PEG 20
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20
Uricase is an enzyme (found in most mammals but not humans) that converts poorly soluble uric acid into highly soluble allantoin. Because humans lack uricase, they are prone to develop elevated levels of uric acid, which can form crystals in the joints and soft tissues. In those which chronically elevated uric acid, gout may develop. In the setting of acute rises in uric acid, seen for example in tumor lysis syndrome, uric acid crystals can damage the renal tubules. Uricase-PEG 20 is a recombinant uricase conjugated with multiple PEG molecules designed to prolong the half-life and decrease the immunogenicity of uricase. This study will characterize the safety, pharmacokinetics and pharmacodynamics of intramuscular Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in gout. ;
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04060173 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
|
Phase 1 | |
| Not yet recruiting |
NCT06187519 -
UR+AIMS Gout Wearable Skin Uric Acid Monitor Study
|
N/A | |
| Completed |
NCT03635957 -
Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout
|
Phase 4 | |
| Completed |
NCT04966325 -
Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
|
Early Phase 1 | |
| Completed |
NCT03015948 -
A Single Dose Study of SHR4640 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT02855437 -
Novel Methods for Ascertainment of Gout Flares -A Pilot Study
|
N/A | |
| Active, not recruiting |
NCT02702375 -
Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases
|
N/A | |
| Completed |
NCT01407874 -
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
|
Phase 2 | |
| Completed |
NCT00985127 -
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
|
Phase 2 | |
| Completed |
NCT00995618 -
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
|
Phase 2 | |
| Terminated |
NCT04987294 -
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
|
Phase 2 | |
| Completed |
NCT03291782 -
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT03388515 -
A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects.
|
Phase 1 | |
| Completed |
NCT06189404 -
Effect of Tigulixostat on the Pharmacokinetics of Theophylline
|
Phase 1 | |
| Enrolling by invitation |
NCT03336203 -
The Impact of Urate-lowering Therapy on Kidney Function (IMPULsKF)
|
Phase 4 | |
| Recruiting |
NCT05586958 -
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
|
Phase 3 | |
| Recruiting |
NCT04047394 -
A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers
|
Phase 1 | |
| Not yet recruiting |
NCT05507723 -
Tight Control of Gouty Arthritis Compared to Usual Care
|
N/A | |
| Recruiting |
NCT06056570 -
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia
|
Phase 1/Phase 2 | |
| Completed |
NCT02557126 -
Study of URC102 to Assess the Safety and Efficacy in Gout Patients
|
Phase 2 |