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

NCT07175662 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • High-grade Squamous Intraepithelial Lesion (HSIL)

Interventions

BIOLOGICAL

NWRD08 administered by electroporation

NWRD08 delivered via IM injection + electroporation using TERESA device

BIOLOGICAL

Placebo administered by electroporation

Placebo delivered via IM injection + electroporation using TERESA device

Sponsors & Collaborators

  • Newish Biotech (Wuxi) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2027-05-30
Completion
2027-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07175662 on ClinicalTrials.gov