Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-14
Brief Title:
A Trial to Evaluate Safety and Efficacy of a Product Named VGN-R09b in Patients With Parkinsons Disease
Sponsor:
Shanghai Vitalgen BioPharma Co Ltd
Organization:
Shanghai Vitalgen BioPharma Co Ltd
Study Overview
Official Title:
A Phase ⅠbⅡ Study to Evaluate the Tolerability Safety and Efficacy of VGN-R09b in Patients With Parkinsons Disease
Status:
NOT_YET_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:
A phase ⅠⅡ study to evaluate the tolerability safety and efficacy of VGN-R09b in pa-tients with Parkinsons disease
Detailed Description:
In the open-label dose escalation part 3 dose cohorts will be explored with 3 subjects per cohort
Cohort 1 3 subjects on 801011 vg for at least 4 weeks post infusion Cohort 2 3 subjects on 161012 vg for at least 4 weeks post infusion Cohort 3 3 subjects on 321012 vg for at least 4 weeks post infusion In the dose-escalation part each cohort follows the principle of sentinel administration ie one subject will be enrolled and dosed first in each cohort If no significant safety risk is observed within 4 weeks after administra-tion the remaining 2 subjects will be dosed
Additional cohorts andor a safe low and high dose will be determined by the safety review committee SRC to initiate Part II
Cohort 1 3 subjects on 801011 vg for at least 4 weeks post infusion Cohort 2 3 subjects on 161012 vg for at least 4 weeks post infusion Cohort 3 3 subjects on 321012 vg for at least 4 weeks post infusion In the dose-escalation part each cohort follows the principle of sentinel administration ie one subject will be enrolled and dosed first in each cohort If no significant safety risk is observed within 4 weeks after administra-tion the remaining 2 subjects will be dosed
Additional cohorts andor a safe low and high dose will be determined by the safety review committee SRC to initiate Part II
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