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

Официальное название

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

Обзор

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).

Подробное описание

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?

Вмешательства

• Препарат LCFA-01
  LCFA-01 Drug Product is a soft gelatin capsule, containing oleic acid at 2 dosage strengths (200 mg and 400 mg).
• Препарат 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.

Первичные конечные точки

• Treatment-emergent adverse events (TEAEs) [Срок оценки: Day 1 to Day 14]
• Clinically significant changes in Physical examinations [Срок оценки: Baseline, Day 2, Day 8, Day 10, Day 14]
• Clinically significant changes in Vital Signs as per protocol [Срок оценки: Baseline, Day2, Day 8, Day 10, Day 14]
• Clinically significant changes in Safety Laboratory Parameters as per protocol [Срок оценки: Baseline, Day 1, Day 2, Day 8, Day 10]
• Self-Reported Symptoms-abnormal vaginal odor [Срок оценки: Baseline to Day 14]
• Self-Reported Symptoms-pain, tenderness [Срок оценки: Baseline to Day 14]
• Self-Reported Symptoms- dyspareunia [Срок оценки: Baseline to Day 14]
• Self-Reported Symptoms- dysmenorrhea/cramping with menses [Срок оценки: Baseline to Day 14]
• Self-Reported Symptoms- vaginal vulvar itching [Срок оценки: Baseline to Day 14]
• Self-Reported Symptoms-vulvar edema [Срок оценки: Baseline to Day 14]

Вторичные конечные точки (4)

• PK parameters derived from plasma concentration for Maximum concentration (Cmax) [Срок оценки: On Day 1, 2, 8, 10]
• Observed concentrations of LCFA-01 in vaginal samples post-dosing [Срок оценки: Day 1, 2, 8, 10, 14]
• PK parameters derived from plasma concentration for Area Under the Curve (AUC) [Срок оценки: On Day 1, 2, 8, 10]
• PK parameters derived from plasma concentration for Time to maximum concentration( Tmax) [Срок оценки: On Day 1, 2, 8, 10]

Критерии участия

Критерии включения

• Females aged 18 to 40 years (inclusive) who are pre-menopausal at the time of providing informed consent
• You should be generally healthy, with no major past illnesses, and your doctor should not see anything concerning during your check-up before starting the study.
• Your BMI (a measure of weight and height) must be between 18.0 and 34.9.
• You must be a non-smoker or only an occasional smoker. If you smoke 2 cigarettes or less per week (or similar, like vaping or cigars), you may still join, depending on the study doctor's decision.
• Your blood and urine test results should be normal, unless the study doctor decides that a slightly abnormal result is not a problem.
• You must test negative for common sexually transmitted infections (STIs) at the screening visit.
• You must not be pregnant at Screening or when you join the study.
• You should have regular periods, unless you are using hormonal birth control that stops your periods. If you do have regular periods, you will join the study within 5 days after your period ends.
• You must agree not to use any vaginal products (like creams, gels, or suppositories) during the study.
• You must agree not to have sexual intercourse during the study and also avoid:

receptive oral sex anal sex vaginal sex toys

• If you can become pregnant, you must use a reliable form of birth control starting from Screening until 90 days after your last dose of the study product.(Using only condoms is not enough.)
• You must be willing and able to come to all required study visits.
• You must be willing to sign a consent form after the study has been explained to you, including how your samples may be stored for future research.

Критерии исключения

• Women who currently have moderate or severe vaginal symptoms (such as pain, itching, burning, or unusual discharge) at the Screening visit cannot join the study.
• Women with physical or mental health conditions that, in the opinion of the study doctor, would make it difficult for them to follow the study rules or finish the study will not be able to participate.
• Women who have had certain surgeries, such as:
• removal of the uterus (full or partial hysterectomy) major surgeries on the cervix, vagina, or uterus (for example: cervical cone biopsy,removal of the cervix, or major uterine surgery)
• cannot participate because these procedures may change the vaginal or reproductive anatomy, which could affect study results.
• Women with certain medical conditions, including:

a. Serious diseases of the vagina, cervix, or uterus, such as:

• cancers of the female reproductive system
• endometriosis
• chronic or recurrent vaginal infections

b. Uncontrolled genital herpes, meaning they had at least one active outbreak in the past 6 months.

c. Serious health problems such as: heart disease or a past heart attack chronic lung disease (like COPD) chronic kidney failure severe liver disease (cirrhosis) or any other serious condition that the study doctor believes would make it unsafe to join the study.

d. Any condition that would require using steroid medicines inside the genital area during the study. (Steroid creams used on the skin, inhalers, or nose sprays are allowed.) e. A yeast infection (vulvovaginal candidiasis) found during Screening. f. Repeated episodes of bacterial vaginosis (BV), meaning two or more episodes in the past year.

• Women who have ever had an autoimmune disease cannot join the study.
• Autoimmune diseases happen when the body's immune system attacks its own tissues. Examples include:

Hashimoto's thyroid disease Pernicious anemia Addison's disease Rheumatoid arthritis Lupus Multiple sclerosis Myasthenia gravis Grave's disease Celiac disease Psoriasis Sarcoidosis Scleroderma Diabetes (Type 1)

• Also, anyone who shows signs of an autoimmune disease now, or is taking medicines that weaken the immune system, may be excluded based on the study doctor's judgment.
• Women who were diagnosed with a cervicovaginal infection (such as gonorrhea, chlamydia, trichomonas, or Mycoplasma genitalium) within 30 days before Screening cannot join.
• Women who had an infection requiring antibiotics or antifungal medicines within 14 days before Screening cannot join.
• Women who used any vaginal cleaning practices in the past 14 days cannot participate.

This includes:

vaginal douching using products to clean, wash, dry, or "freshen" the vagina

• Women who test positive for syphilis at Screening cannot join.
• Women who have HIV cannot participate, whether the infection is treated, untreated, or well controlled.
• Women who have chronic hepatitis B infection cannot join the study.
• Women who are currently taking medicine to treat hepatitis C cannot participate.
• Women who have used long-acting investigational medicines, such as injectable HIV prevention products (PrEP), within the past year cannot join.
• Women who are using a non-hormonal IUD, like the copper T IUD, or a hormonal vaginal ring, cannot take part in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Allied Health Hub Morayfield — Brisbane

Идентификаторы

NCT: NCT07514416 · FLOURISH-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗