NCT07514416

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

A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LCFA-01, an Intravaginal Product, in Healthy Participants for Bacterial Vaginosis Treatment

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

This study is testing a new vaginal product called LCFA-01 for the first time in humans. The goal is to see: 1. if it is safe, 2. if women can tolerate it well, and 3. what happens to the product inside the body after it's used. Up to 30 healthy adult women who are 18 years to 40 years of age and who are not pregnant \& not in menopause. Women first go through a "Screening period" lasting up to 35 days. Doctors make sure they are healthy and can join the study. The whole study period lasts 2 weeks: Week 1: Using the product Women use the vaginal product once a day for 7 days. Day 1 and Day 2: They use it at the clinic, so doctors can watch closely for safety. Day 3 to Day 7: They use it at home. Women also take their own vaginal swab samples every day at home. During the first week, they take the swab before using the product. Week 2: No product Women stop using the product but continue to self-swab at home. They come back for a check-up at the end of this week. There will be 2 groups (cohorts), each trying a different amount of LCFA-01: In each group, 2 out of 3 women get LCFA-01 1 out of 3 gets a placebo (a harmless, inactive product) This helps researchers compare effects. Only 2 women (one gets LCFA-01, one gets placebo) are treated first in each group. Doctors watch them for 24 hours. If everything looks safe, the rest of the women in that group can begin the study. Are there any side effects? Is the product safe and comfortable to use? Does any of the product get into the bloodstream? How long does the product stay in the vagina? How does it affect the vaginal environment?

Conditions

• Bacterial Vaginosis Treatment

Interventions

Type	Name	Description
DRUG	LCFA-01	LCFA-01 Drug Product is a soft gelatin capsule, containing oleic acid at 2 dosage strengths (200 mg and 400 mg).
DRUG	Placebo	LCFA-01 Placebo is a soft gelatin capsule, of which the composition is similar to that of LCFA-01 Drug Product, but without the active pharmaceutical ingredient.

Timeline

• Start date: 2026-05-06
• Primary completion: 2026-07-17
• Completion: 2026-07-31
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Australia