High-risk HPV (Any Strain)Phase 2NCT07572396
Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
A Phase 2 study testing EGCG and Quinine Sulfate Vaginal Suppository in people with High-risk HPV (Any Strain) and LSIL, Low Grade Squamous Intraepithelial Lesion, run by Amplexd Therapeutics, Inc. at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion, ASC-US
- What is being tested?
- EGCG and Quinine Sulfate Vaginal Suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Apr 2026to 27 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin, New Territories
Bell (Hei Yi) Yung, +852 5165 6846, p2trialhk@amplexd.com
Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion, ASC-US, HPV Infection, Cervical Abnormalities, Uterine Cervical Dysplasia
- Being tested
- EGCG and Quinine Sulfate Vaginal Suppository, Placebo
- 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
- Medical subject headings
- Squamous Intraepithelial Lesions, Atypical Squamous Cells of the Cervix, Papillomavirus Infections, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGCG and Quinine Sulfate Vaginal SuppositoryDrug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: From enrollment to post-end of treatment follow-up (Day 50 visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion27 Dec 2026 (estimated)
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk HPV (Any Strain)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amplexd Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA, Principal investigator, Prince of Wales Hospital, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572396
- Sponsor's protocol ID
- AMP.2025.001
- Other IDs
- 200922, 2025.300
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sponsor is in the process of finalizing an IPD sharing policy and governance framework.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07572396
- Acronym / sponsor ID
- AMP.2025.001
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Amplexd Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Chinese University of Hong Kong
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 27 Dec 2026 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysplasix™ Intravaginal Suppositories | Experimental | Drug: EGCG and Quinine Sulfate Vaginal SuppositoryEpigallocatechin 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. |
| Placebo Intravaginal Suppositories | Placebo comparator | Other: PlaceboSemisolid 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGCG and Quinine Sulfate Vaginal SuppositoryEpigallocatechin 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. | Drug | Dysplasix™ Intravaginal Suppositories |
| PlaceboSemisolid 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 Intravaginal Suppositories |
Primary outcome
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.
Time frame: From enrollment until post-end of treatment follow up (Day 50 visit)
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).
Regression of cervical cytology present at study entry
Time frame: From enrollment to post-end of treatment follow-up (Day 50 visit)
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
Clearance of hr-HPV genotype present at study entry
Time frame: From enrollment to post-end of treatment follow-up (Day 50 visit)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided. The sponsor is in the process of finalizing an IPD sharing policy and governance framework.
Related trials for High-risk HPV (Any Strain)
Not yet recruitingPhase 2
Study Assessing Reduced HPV Infectivity and Transmission in HPV-Positive Women Following Vaccination With 9vHPV
HPV, High-risk HPV (Any Strain)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA principal investigator
Prince of Wales Hospital, Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGCG and Quinine Sulfate Vaginal Suppository in people with High-risk HPV (Any Strain) and LSIL, Low Grade Squamous Intraepithelial Lesion, run by Amplexd Therapeutics, Inc. at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Manager (713-933-9640, p2trialhk@amplexd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From enrollment until post-end of treatment follow up (Day 50 visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.