Safety and Efficacy Study of Intramuscular Uricase-PEG 20
NCT01038947 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2009-12-24
Summary
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20
Conditions
- Gout
- Hyperuricemia
Interventions
- BIOLOGICAL
-
Uricase-PEG 20
Intramuscular injection of Uricase-PEG 20 without premedication
Sponsors & Collaborators
-
EnzymeRx
lead INDUSTRY
Principal Investigators
-
Anthony S Fiorino, MD, PhD · EnzymeRx, LLC
-
Patricia Pardo, MD · MRA Clinical Research
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2010-04-30
- Completion
- 2010-05-31
Countries
- United States
Study Locations
More Related Trials
-
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
NCT00675103 ·Status: COMPLETED ·Phase: PHASE3
-
Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
NCT00111657 ·Status: COMPLETED ·Phase: PHASE2
-
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
NCT01356498 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients
NCT02290210 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels
NCT02464605 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects.
NCT03388515 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
NCT00080210 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
NCT00985127 ·Status: COMPLETED ·Phase: PHASE2
-
Study of FYU-981 in Hyperuricemia With or Without Gout
NCT02344862 ·Status: COMPLETED ·Phase: PHASE2
-
Hyperuricemia and Diabetic Nephropathy
NCT04799925 ·Status: UNKNOWN
-
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
NCT03291782 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects
NCT03906006 ·Status: COMPLETED ·Phase: PHASE1
-
Study of FYU-981 in Hyperuricemia With or Without Gout
NCT03006445 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout
NCT01336686 ·Status: COMPLETED ·Phase: PHASE2
-
Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients
NCT03857165 ·Status: COMPLETED ·Phase: PHASE1
-
Study of URC102 to Assess the Safety and Efficacy in Gout Patients
NCT02557126 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
NCT03934099 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant
NCT04087720 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
NCT04060173 ·Status: COMPLETED ·Phase: PHASE1
-
D-0120 Safety and PK/PD Study in China
NCT03923868 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients
NCT05504083 ·Status: COMPLETED ·Phase: PHASE2
-
Study of FYU-981 in Hyperuricemia With or Without Gout
NCT02416167 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
NCT07116746 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Gout Dose Response Study
NCT00955981 ·Status: COMPLETED ·Phase: PHASE2
-
Single Dose Study of SHR4640 in Healthy Subjects
NCT02815839 ·Status: COMPLETED ·Phase: PHASE1