Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities

Summary

The goal of this clinical trial is to learn if an investigational vaginal suppository therapy works to treat low-grade cervical lesions (ASC-US and LSIL) associated with high-risk human papillomavirus (hr-HPV) infection in women. It will also learn about the safety and tolerability of this investigational therapy. The main questions it aims to answer are:

* Does the investigational therapy lead to regression of cervical lesions?
* Does the investigational therapy help clear hr-HPV infection?
* Do any adverse effects occur from using this medical product?

Researchers will compare the investigational therapy to a placebo (a look-alike substance that contains no active drug) to see if the investigational therapy works.

Participants will:

* Be screened for hr-HPV, cervical abnormalities, and other conditions to be assessed for eligibility
* Self-administer 15 doses of the investigational therapy or placebo as a vaginal suppository over 19 calendar days
* Attend scheduled clinic visits for examinations, testing, and monitoring for a period of two months
* Undergo assessments to evaluate cervical lesion status, hr-HPV infection, and safety outcomes
* Keep a daily diary of investigational therapy use and associated information

Conditions

• High-risk HPV (Any Strain)
• LSIL, Low Grade Squamous Intraepithelial Lesion
• ASC-US
• HPV Infection
• Cervical Abnormalities
• Uterine Cervical Dysplasia

Interventions

DRUG

EGCG and Quinine Sulfate Vaginal Suppository

Epigallocatechin gallate + Quinine Sulfate - Dysplasix™ Semisolid Intravaginal suppository 15 doses administered over the span of 3 x 5 consecutive nightly administration of investigational therapy, followed by a two day pause between cycles for a total of 15 doses administered over 19 calendar days. If menses occurs during treatment, investigational product use should be suspended until menses seizes and continued thereafter until 15 doses have been administered.

OTHER

Placebo

Semisolid Intravaginal Suppository 15 doses administered over the span of 3 x 5 consecutive nightly administration of investigational therapy, followed by a two day pause between cycles for a total of 15 doses administered over 19 calendar days. If menses occurs during treatment, investigational product use should be suspended until menses seizes and continued thereafter until 15 doses have been administered.

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong

  collaborator OTHER

• Chinese University of Hong Kong

  collaborator OTHER

• Amplexd Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA · Prince of Wales Hospital, Chinese University of Hong Kong

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

2026-04-30

Primary Completion

2026-12-27

Completion

2027-01-27

FDA Drug

Yes

Countries

• Hong Kong

Study Locations