Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511349
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Clinical Exploration Study of YOLT-203 in the Treatment of Type 1 Primary Hyperoxaluria PH1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Exploration Study of YOLT-203 in the Treatment of Type 1 Primary Hyperoxaluria PH1
Status:
RECRUITING
Status Verified Date:
2024-08
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 study is a single-arm open-label single-dose dose-escalation trial aiming to evaluate the safety and tolerability of YOLT-203 in the Chinese population with type 1 primary hyperoxaluria PH1 and to preliminarily assess the effect of a single dose of YOLT-203 on the plasma oxalate level
In this study the maximum screening period of the main study is 60 days the treatment day is Day 1 D1 and the safety follow-up period is up to Week 52 after administration In addition subjects within the first dose group can voluntarily receive a second treatment with the test drug at the effective dose level
After the end of the main study the subjects will undergo long-term follow-up According to the requirements of the Technical Guidelines for Long-Term Follow-up Clinical Studies of Gene Therapy Products Trial issued by the CDE the long-term follow-up is up to 15 years after administration
In this study the maximum screening period of the main study is 60 days the treatment day is Day 1 D1 and the safety follow-up period is up to Week 52 after administration In addition subjects within the first dose group can voluntarily receive a second treatment with the test drug at the effective dose level
After the end of the main study the subjects will undergo long-term follow-up According to the requirements of the Technical Guidelines for Long-Term Follow-up Clinical Studies of Gene Therapy Products Trial issued by the CDE the long-term follow-up is up to 15 years after administration
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