To Test a New Drug (LCFA-01) for Safety and PK in Healthy Adults for Bacterial Vaginosis Infection.

This study is being done to check how safe and comfortable LCFA-01 is when used inside the vagina. LCFA-01 is a natural product that contains oleic acid, and it comes as a soft gel capsule that participants will place in the vagina using their fingers. The main purpose of the study is to make sure the product is safe and does not cause any problems or discomfort. The study will also measure how much of the product stays in the vagina and whether any of it enters the bloodstream. This helps researchers understand how the body absorbs and handles the product. Finally, the study will also look at early signs of how the product might affect the natural bacteria in the vagina. In the future, LCFA-01 may be used to treat bacterial vaginosis (BV).

NCT Number	NCT07514416
Lead Sponsor	Massachusetts General Hospital Collaborators: Caroline Mitchell, MD, MPH, Massachusetts General Hospital, Meilin Zhu, PhD, Massachusetts General Hospital
Conditions	Bacterial Vaginosis Treatment
Enrollment	30 participants
Start Date	2026-04-28
Primary Completion	2026-08-12 (estimated)
Study Completion	2026-08-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-14