drugset / Trial / NCT07175662
Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD08 administered by intramuscular (IM) injection followed by electroporation (EP) in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV18.
Timeline
- Start
- 2025-11-11
- Primary completion
- 2027-05-30
- Completion
- 2027-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NWRD08 | Vaccine | 2 mg | Intramuscular |
| Subject | NWRD08 | Vaccine | 4 mg | Intramuscular |