Gout Clinical Trial
Official title:
A Randomized, Double-blinded, Placebo-controlled, Single-dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SSS11 Administered Intravenously in Healthy Volunteers.
SSS11 is pegsiticase consisting of a recombinant uricase conjugated to multiple 20kDa PEG molecules. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose SSS11 administered intravenously in healthy volunteers.
Objectives:
Primary:
• To assess the safety, tolerability of single dose SSS11 in healthy subjects
Secondary:
• To assess the pharmacokinetics, pharmacodynamics and immunogenicity of SSS-11 in healthy
subjects
Enrollment and Number of Arms (planned):
40 subjects will be assigned into 5 dosing cohorts (1.5, 3, 6, 12 and 24mg) with 5-10
subjects each.
Original primary outcome Measures:
Safety: Physical exam，ECG，Clinical laboratory tests，AE，SAE Tolerance assessment：MDT，DLT
Original secondary outcome Measures:
pharmacokinetics: Cmax, Tmax, AUC, CL, Vd, t1/2 pharmacodynamics: level of serum uric acid
Immunogenicity ：anti-SSS11, anti-uricase and anti-PEG antibodies
;
| 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 | |
| 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 | |
| Completed |
NCT02246673 -
RDEA3170 and Febuxostat Combination Study in Gout Subjects
|
Phase 2 |