Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06276101
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-18
Brief Title:
NWRD08 DNA Plasmid for HPV-16 andor HPV-18 Related Cervical HSIL
Sponsor:
Newish Technology Beijing Co Ltd
Organization:
Newish Technology Beijing Co Ltd
Study Overview
Official Title:
Phase I Safety and Tolerability Study of NWRD08 in HPV-16 andor HPV-18 Related Cervical High-grade Squamous Intraepithelial Lesion HSIL Patients
Status:
RECRUITING
Status Verified Date:
2024-02
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 single-arm open label multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine NWRD08 in patients HPV-16 andor HPV-18 related cervical HSIL
Detailed Description:
This study is divided into three dose groups1mg 4mg and 8mg Each patient will be administered NWRD08 by electroporation in entire study period The Maximum Tolerated Dose of NWRD08 will be determined by the classical 33 dose escalation schedule The number of patients will be ranged from 9 to 18
After the completion of treatment the subjects shall continue to receive safety follow-up until 28 days after the last administration Colposcopy and biopsy were performed at week 12 if HSIL was identified loop electro-surgical excisional procedure LEEP or cold Knife conization CKC will be performed when necessary The subjects were then followed up at week 36 and all adverse events shall revert to level I or all adverse events shall be clinically stable whichever is later achieved
After the completion of treatment the subjects shall continue to receive safety follow-up until 28 days after the last administration Colposcopy and biopsy were performed at week 12 if HSIL was identified loop electro-surgical excisional procedure LEEP or cold Knife conization CKC will be performed when necessary The subjects were then followed up at week 36 and all adverse events shall revert to level I or all adverse events shall be clinically stable whichever is later achieved
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