RecruitingNot Applicable

NWRD09 for Persistent Cervical HPV16 Infection

China60 participantsStarted 2026-02-10

Plain-language summary

This is a randomized, double-blind, placebo controlled study to determine the efficacy and safety of NWRD09 in adult women with persistent cervical HPV16 infection.

Who can participate

Age range

45 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Female, aged 45 to 65 years (inclusive).
. Documented positive result for HPV 16 from a cervical sample collected at screening, with a confirmed duration of positivity for at least 12 months before screening.
. Satisfactory colposcopy examination. For participants with concomitant cervical LSIL, the entire aceto-white staining area or the suspected cervical intraepithelial neoplasia (CIN) lesion, including the upper border of the transformation zone, must be fully visualized.
. Adequate organ function within 1 week before the first dose, defined as:

Exclusion criteria

. Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade cervical, vulvar, vaginal, or anal intraepithelial neoplasia, or invasive cancer.
. Cervical cytology results indicating ASC-H (Atypical Squamous Cells - cannot exclude HSIL), HSIL (High-grade Squamous Intraepithelial Lesion), SCC (Squamous Cell Carcinoma), AGC (Atypical Glandular Cells), or AIS; \*Exception: Participants with ASC-H or HSIL may be enrolled if histopathological evidence confirms no lesion or CIN1, upon investigator's assessment.\*.
. Pregnant or lactating women, or individuals planning to conceive during the study period.
. Participation in another clinical trial within 30 days before screening, or currently within the observational follow-up period of another clinical trial.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants with virologically-proven clearance of HPV 16 at week 16.

Timeframe: Week 16

Trial details

NCT IDNCT07710703

SponsorNewish Biotech (Wuxi) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Jian Zhao, M.D.

+86-15601199333 854496@qq.com

View on ClinicalTrials.gov More Persistent Cervical HPV16 Infection trials