drugset / Trial / NCT07712692

Evaluation of NWRD09 for HPV-16 Related Cervical HSIL

NCT07712692 ↗

Phase 2 Not yet recruiting 156 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 NWRD09 administered by intramuscular (IM) injection 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.

Timeline

Start
2026-08-01
Primary completion
2027-06-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject NWRD09 Messenger RNA (mRNA) 10 ug Intramuscular
Subject NWRD09 Messenger RNA (mRNA) 20 ug Intramuscular