Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-03
Brief Title:
A Dose Escalation Study of IG3018 in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
Sponsor:
Intelligem Therapeutics Australia Pty Ltd
Organization:
Intelligem Therapeutics Australia Pty Ltd
Study Overview
Official Title:
A Dose Escalation Study of IG3018 to Evaluate the Safety Tolerability Efficacy and Pharmacokinetics in Subjects With Hyperuricemia With or Without Chronic Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase III clinical study to evaluate the safety tolerability PK and efficacy of IG3018 tablet in hyperuricemia HUA subjects with or without CKD
Detailed Description:
The study has two parts
Part 1 is a randomized double-blind placebo-controlled dose escalation study in hyperuricemia subjects without CKD Initiation Dose shall be at 025 g tablets Cohort A and doses are escalated to 05 g Cohort B and then to 10 g Cohort C in a planned manner
Part 2 is an open-label proof of concept study involving hyperuricemia subjects with advanced predialysis CKD Stage 3a Stage 3b and Stage 4 and treated with two doses 05 g BID IG3018 Cohort D and 10 g BID IG3018 Cohort E
Part 1 is a randomized double-blind placebo-controlled dose escalation study in hyperuricemia subjects without CKD Initiation Dose shall be at 025 g tablets Cohort A and doses are escalated to 05 g Cohort B and then to 10 g Cohort C in a planned manner
Part 2 is an open-label proof of concept study involving hyperuricemia subjects with advanced predialysis CKD Stage 3a Stage 3b and Stage 4 and treated with two doses 05 g BID IG3018 Cohort D and 10 g BID IG3018 Cohort E
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None