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NOT YET RECRUITING
NCT07514416
PHASE1

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-05-06

Completion Date

2026-07-31

Last Updated

2026-04-07

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Allied Health Hub Morayfield

Brisbane, Queensland, Australia