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Evaluation of NWRD09 for HPV-16 Related Cervical HSIL

NCT07712692 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-07-17

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 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.

Conditions

  • High-grade Squamous Intraepithelial Lesion (HSIL)

Interventions

BIOLOGICAL

NWRD09 Injection

NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.

BIOLOGICAL

NWRD09 Placebo

Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.

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
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

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 NCT07712692 on ClinicalTrials.gov