Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06629376
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Safety Tolerability and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Tolerability Pharmacokinetics and Preliminary Pharmacological Studies of SSS11 in Patients With Gout and Hyperuricemia After Multiple Administrations Dose Escalation Randomized Double-blind Placebo-controlled Trials
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a safety tolerability pharmacokinetics and preliminary pharmacological study of multiple administration dose escalation randomized double-blind placebo-controlledThe main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of PEGylated recombinant Candida urate oxidase test drug code SSS11 in patients with gout and hyperuricemiaThe experimental period includes a screening period of 4 weeks a treatment period of 4 or 8 weeks and an observation period of 4 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None