Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458010
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-17
Brief Title:
Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia FH
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Clinical Exploration Trial of YOLT-101 in the Treatment of Familial Hypercholesterolemia FH
Status:
RECRUITING
Status Verified Date:
2024-06
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 study is a single arm open single dose escalation trial aimed at evaluating the safety and tolerability of YOLT-101 administration in patients with familial hypercholesterolemia Determination of YOLT-101 OBD Preliminary evaluation of the effects of single administration of YOLT-101 on plasma lipid and lipoprotein levels
Note OBD is defined as the dosage at which plasma PCSK9 protein levels decrease between 60 and 95 from baseline on the 28th day after YOLT-101 administration OBD Maximum Tolerable Dose MTD
In this study the longest screening period for the main study was 42 days the treatment day was Day 1 D1 and the safe follow-up period was up to 52 weeks after medication In the main study when OBD occurs additional subjects will be added to the dose group specific number of cases will be negotiated between the cooperating organization and investigators for further validation In addition subjects in the first dose group can voluntarily receive a second drug administration of OBD level
After the completion of the main study participants will undergo long-term follow-up According to the Technical Guidelines for Long term Follow up Clinical Research of Gene Therapy Products Trial released by CDE a long-term follow-up until 15 years after the medicine administration is required
Note OBD is defined as the dosage at which plasma PCSK9 protein levels decrease between 60 and 95 from baseline on the 28th day after YOLT-101 administration OBD Maximum Tolerable Dose MTD
In this study the longest screening period for the main study was 42 days the treatment day was Day 1 D1 and the safe follow-up period was up to 52 weeks after medication In the main study when OBD occurs additional subjects will be added to the dose group specific number of cases will be negotiated between the cooperating organization and investigators for further validation In addition subjects in the first dose group can voluntarily receive a second drug administration of OBD level
After the completion of the main study participants will undergo long-term follow-up According to the Technical Guidelines for Long term Follow up Clinical Research of Gene Therapy Products Trial released by CDE a long-term follow-up until 15 years after the medicine administration is required
Detailed Description:
None
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