Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients With High-Risk HPV (Hr-HPV) and Either (1) ASC-US or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL)

NCT07572396 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: AMP.2025.0012009222025.300
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hpv; human papillomavirus; CIN1; LSIL; EGCG; Quinine Sulfate; abnormal Pap; ASCUS; gynecology; precancerous lesions; atypical squamous cells; low grade squamous intraepithelial lesions; Epigallocatechin gallate; women's health; abnormal cytology; cervical cytology

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Dysplasix™ Intravaginal Suppositories

EXPERIMENTAL

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

Placebo Intravaginal Suppositories

PLACEBO COMPARATOR

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

Interventions

EGCG and Quinine Sulfate Vaginal Suppository DRUG

Epigallocatechin gallate 50mg + Quinine Sulfate 50mg - 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.

Dysplasix™ Intravaginal Suppositories

Placebo OTHER

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 Intravaginal Suppositories

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria to be eligible to enroll in the study:
• Participants capable of giving informed consent
• Females, ages 18 to 65 years old at the time of signature of the informed consent form.
• Participants who are able to correctly self-administer the intravaginal suppositories
• One or more hr-HPV oncotypes as confirmed by HPV test
• Participants with ASCUS or LSIL abnormalities as confirmed by cytology
• Immune competent
• Participants of childbearing potential must have a negative pregnancy test at screening.
• Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study
• Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• Presence of HSIL at screening cytology
• Evidence of glandular abnormalities (AGC/AIS) at screening cytology
• BMI below 16
• Pregnant or nursing females
• Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens
• \. Using a vaginal contraceptive ring
• \. History of irregular menstrual cycles or routine intermenstrual bleeding
• \. Active autoimmune disease
• \. Taking prohibited concomitant medications
• \. Concurrent malignancy except for non-melanoma skin lesions
• \. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)

Sponsors & Collaborators

• Amplexd Therapeutics, Inc.: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Squamous Intraepithelial Lesions; Atypical Squamous Cells of the Cervix; Papillomavirus Infections; Uterine Cervical Dysplasia

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes

Study Officials

• Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA

  Prince of Wales Hospital, Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trial Manager

CONTACT

438-795-5450; p2trialhk@amplexd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 27, 2026
• Study Completion (Estimated): January 27, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

HK (1)