drugset / Trial / NCT07175662

Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL

NCT07175662 ↗

Phase 2 Recruiting 150 enrolled Newish Biotech (Wuxi) Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject NWRD08 Vaccine 2 mg Intramuscular
Subject NWRD08 Vaccine 4 mg Intramuscular