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

A Phase II, Randomized, Double-blind, Placebo-Controlled, Proof of Concept Study to Assess the Safety and Efficacy of Dysplasix™ Intravaginally-Administered Suppositories in Patients With High-Risk Human Papillomavirus (Hr-HPV) as Determined by HPV Testing, and Accompanied by Either (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL), as Determined by Cytology

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

Study Overview

• Status: Recruiting
• Conditions: ASC-US; Uterine Cervical Dysplasia; HPV Infection; Cervical Abnormalities; High-risk HPV (Any Strain); LSIL, Low Grade Squamous Intraepithelial Lesion
• Intervention / Treatment: Other: Placebo; Drug: EGCG and Quinine Sulfate Vaginal Suppository

Detailed Description

AMP.2025.001 is a Phase II, Double-Blind, randomized, Placebo-Controlled, Proof-of-Concept study to assess the safety and efficacy of Dysplasix™ Intravaginal Suppositories in females with hr-HPV and one of the following: cytologically confirmed (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL)

Participants must undergo both (1) HPV testing and (2) a liquid-based exfoliative cytology test.

If, at laboratory screening, high-risk HPV and either (1) ASC-US or (2) LSIL cytologic abnormalities are detected, participants will be eligible for inclusion. If high-grade SIL (HSIL) or glandular abnormalities (AGC-NOS, AGC-N, AIS) are detected, participants will be excluded.

Eligible participants with high-risk HPV and either (1) ASC-US or (2) LSIL cytology will be randomized in a 1:1 ratio to Dysplasix™ or a matching Placebo until participants who meet eligibility are enrolled. Suppositories (Dysplasix™) or placebo will be intravaginally self-administered once nightly for a fifteen (15) day course of therapy (3 cycles of 5 days followed by two days off between cycles) applied at night immediately before sleep, beginning shortly after the end of menses. Tolerability of the drug will be recorded in daily participant diaries and assessed at regularly scheduled clinical assessment visits.

Participants will undergo complete cervical screening, including hr-HPV testing and cytology 30 (+/- 14) days after completion of treatment in addition to adverse events assessments.

Adverse events are evaluated using Common Terminology Criteria for Adverse Events v5.0.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Trial Manager; Phone Number: 713-933-9640; Email: p2trialhk@amplexd.com

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Bell (Hei Yi) Yung; Phone Number: +852 5165 6846; Email: p2trialhk@amplexd.com
      • Principal Investigator: Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must meet all the following criteria to be eligible to enroll in the study:

1. Participants capable of giving informed consent
2. Females, ages 18 to 65 years old at the time of signature of the informed consent form.
3. Participants who are able to correctly self-administer the intravaginal suppositories
4. One or more hr-HPV oncotypes as confirmed by HPV test
5. Participants with ASCUS or LSIL abnormalities as confirmed by cytology
6. Immune competent
7. Participants of childbearing potential must have a negative pregnancy test at screening.
8. Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study
9. Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

1. Presence of HSIL at screening cytology
2. Evidence of glandular abnormalities (AGC/AIS) at screening cytology
3. BMI below 16
4. Pregnant or nursing females
5. Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens
6. Using a vaginal contraceptive ring
7. History of irregular menstrual cycles or routine intermenstrual bleeding
8. Active autoimmune disease
9. Taking prohibited concomitant medications
10. Concurrent malignancy except for non-melanoma skin lesions
11. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dysplasix™ Intravaginal Suppositories; Epigallocatechin gallate + Quinine Sulfate - 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.	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.
Placebo Comparator: Placebo Intravaginal Suppositories; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine and evaluate the safety and tolerability of Dysplasix™ intravaginal suppository therapy in females with hr-HPV and positive cytology for either ASCUS or LSIL.	Number of participants with serious adverse events (SAEs) or dose-limiting toxicities (DLTs) related to the study intervention assessed using relevant Common Terminology Criteria for Adverse Events (CTCAE).	From enrollment until post-end of treatment follow up (Day 50 visit)
Regression of cervical cytology present at study entry	Participants whose baseline Atypical Cells of Undetermined Significance (ASCUS) or Low-Grade Squamous Intraepithelial Lesions (LSIL) regress to Normal for Intraepithelial Lesions or Malignancies (NILM), 30 days after completion of 15-day course of Dysplasix™ therapy (3 x 5-day cycles), as assessed by cytology	From enrollment to post-end of treatment follow-up (Day 50 visit)
Clearance of hr-HPV genotype present at study entry	Participants whose high-risk human papillomavirus (HPV) genotypes present at study entry become undetectable 30 days after completion of 15-day course of Dysplasix™ therapy (3 x 5-day cycles), as assessed by HPV testing	From enrollment to post-end of treatment follow-up (Day 50 visit)

Collaborators and Investigators

• Sponsor: Amplexd Therapeutics, Inc.
• Collaborators: Chinese University of Hong Kong; Prince of Wales Hospital, Shatin, Hong Kong
• Investigators: Principal Investigator: Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA, Prince of Wales Hospital, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): December 27, 2026
• Study Completion (Estimated): January 27, 2027

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ASCUS; LSIL; women's health; human papillomavirus; gynecology; CIN1; Epigallocatechin gallate; cervical cytology; EGCG; abnormal Pap; precancerous lesions; hpv; Quinine Sulfate; atypical squamous cells; low grade squamous intraepithelial lesions; abnormal cytology
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Infections; Virus Diseases; Uterine Diseases; Genital Diseases, Female; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Precancerous Conditions; Uterine Cervical Diseases; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings; Papillomavirus Infections; Uterine Cervical Dysplasia; Atypical Squamous Cells of the Cervix; Squamous Intraepithelial Lesions; epigallocatechin gallate
• Other Study ID Numbers: AMP.2025.001; 200922 (Other Identifier: Hong Kong Department of Health (Pharmacy and Poisons Ordinance)); 2025.300 (Other Identifier: Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research and Ethics Committee (CREC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The sponsor is in the process of finalizing an IPD sharing policy and governance framework.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes