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
Sponsor study identifier
interventional
30
1 country
1
Study Start
April 28, 2026
Actual (reported)Primary Completion
September 2, 2026
Actual (reported)Study Completion
October 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 4, 2026
Actual (reported)April 7, 2026
Actual (reported)April 28, 2026
Actual (reported)September 2, 2026
Actual (reported)October 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Treatment-emergent adverse events (TEAEs)
Day 1 to Day 14
Clinically significant changes in Physical examinations
Baseline, Day 2, Day 8, Day 10, Day 14
Clinically significant changes in Vital Signs as per protocol
Baseline, Day2, Day 8, Day 10, Day 14
Clinically significant changes in Safety Laboratory Parameters as per protocol
Baseline, Day 1, Day 2, Day 8, Day 10
Self-Reported Symptoms-abnormal vaginal odor
Baseline to Day 14
Self-Reported Symptoms-pain, tenderness
Baseline to Day 14
Self-Reported Symptoms- dyspareunia
Baseline to Day 14
Self-Reported Symptoms- dysmenorrhea/cramping with menses
Baseline to Day 14
Self-Reported Symptoms- vaginal vulvar itching
Baseline to Day 14
Self-Reported Symptoms-vulvar edema
Baseline to Day 14
Self-Reported Symptoms- vulvar erythema
Baseline to Day 14
Self-Reported Symptoms-vulvar lesions
Baseline to Day 14
Self-Reported Symptoms-Bartholin or Skene's gland lesions
Baseline to Day 14
PK parameters derived from plasma concentration for Maximum concentration (Cmax)
On Day 1, 2, 8, 10
Observed concentrations of LCFA-01 in vaginal samples post-dosing
Day 1, 2, 8, 10, 14
PK parameters derived from plasma concentration for Area Under the Curve (AUC)
On Day 1, 2, 8, 10
PK parameters derived from plasma concentration for Time to maximum concentration( Tmax)
On Day 1, 2, 8, 10
Dose 1 (200 mg) Dose 2 (400 mg) Dose Formulation- The soft gelatin capsule is light-to-medium yellow in color and oblong in shape Route of Administration- Vaginal
Route of Administration- Vaginal
LCFA-01 Drug Product is a soft gelatin capsule, containing oleic acid at 2 dosage strengths (200 mg and 400 mg).
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.
Allied Health Hub Morayfield
Brisbane, Queensland, 4506, Australia
First Submitted
March 4, 2026
First Posted
April 7, 2026
Study Start
April 28, 2026
Actual (reported)Primary Completion
September 2, 2026
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
October 22, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 11, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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