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

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

NCT Number	NCT07572396
Lead Sponsor	Amplexd Therapeutics, Inc. Collaborators: Prince of Wales Hospital, Shatin, Hong Kong, Chinese University of Hong Kong
Conditions	High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion, ASC-US, HPV Infection, Cervical Abnormalities, Uterine Cervical Dysplasia
Enrollment	45 participants
Start Date	2026-04-30
Primary Completion	2026-12-27 (estimated)
Study Completion	2027-01-27 (estimated)
Updated on ClinicalTrials.gov	2026-05-14