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NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL

NCT06276101 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-02-23

No results posted yet for this study

Summary

This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL.

Conditions

  • High-grade Squamous Intraepithelial Lesion (HSIL)

Interventions

BIOLOGICAL

NWRD08 administered by electroporation

DNA plasmid delivered via IM injection + electroporation using TERESA device

Sponsors & Collaborators

  • Newish Technology (Beijing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yang Xiang, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-01-25
Primary Completion
2024-12-30
Completion
2025-07-30

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 NCT06276101 on ClinicalTrials.gov