Phase 1 Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability and Acceptability of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Female Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Bacterial Vaginosis
- Sponsor
- AtoGen Co. Ltd
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Changes in Clinical Laboratory Tests, Vital signs (body temperature, respiratory rate, heart rate, blood pressure), Gynaecological Examination, and Physical Examination.
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled, dose escalation, clinical trial enrolling 24 healthy participants. The main subject is to investigate the safety and tolerability of the LABTHERA-001 capsule and to explore the acceptability of the capsule.
Detailed Description
Bacterial vaginosis (BV) is the most common vaginal syndrome frequently found in women. BV is currently mainly treated with antibiotics. However, antibiotic administration can cause various side effects. And one of them is destroying the normal bacteria in the vagina, affecting the balance of the vaginal flora, increasing the likelihood of bacterial vaginosis recurrence, and causing drug resistance of bacteria. Therefore, the importance of fundamental treatment with the recovery of balance in normal vaginal flora is being recognized increasingly. The study drug for this trial, LABTHERA-001, has been derived from the bacteria Lactobacillus plantarum ATG-K2. Administration of the ATG-K2 strain will temporarily colonize the vagina to encourage a more normal microbiome. The main goals of this study are 1. to determine whether LABTHERA-001 is safe and well tolerated in healthy adult women. And 2. to investigate the acceptability of the LABTHERA-001 capsule or matching placebo by completing a satisfaction evaluation questionnaire.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy non-smoking woman aged 18 to 45 years old as of the date of written consent
- •Agrees to maintain her contraceptive method during the clinical trial if she has regular menstrual cycles (21-35 days) or has had amenorrhea for more than 12 weeks before the Screening Visit due to continued use of long-acting progestin or oral contraceptives.
- •Confirmed normal cervical screen test (CST) performed at the Screening Visit
- •Has had sexual experiences that included vaginal intercourse
- •Has experienced gynecological examinations previously
- •Agrees to discontinue the use of the following during the clinical trial period (Screening Visit to End of study visit or early termination visit):
- •products for vaginal insertion (e.g., tampons, menstrual cups, etc.)
- •Other vaginal products (e.g., contraceptive creams, vaginal cleaners, lubricants, etc.)
- •Agrees to be sexually abstinent from 72 hours before the Day 1 visit until the first study visit after final administration of IP (nominally the Day 9 visit).
- •Agrees to continue to use the following highly effective contraceptive methods during the clinical trial period and for at least 30 days after the final dose of study treatment, if woman of child-bearing potential (has experienced menarche and is not permanently sterile or postmenopausal):
Exclusion Criteria
- •Confirmed to have the following urogenital infections from the vaginal discharge test performed at the Screening Visit, or had the following diagnosed urogenital infections within three weeks before the Screening Visit, or has a history of clinically significant urogenital infections at the discretion of the Investigator:
- •Urinary tract infection, bacterial vaginosis, candida vaginitis, trichomonas vaginalis, Neisseria gonorrhoeae, chlamydia trachomatis, treponema pallidum, herpes simplex
- •History of recurrent genital herpes
- •Has the following diagnosed urogenital infections, or had two or more clinically significant urogenital infections within 24 weeks before the Screening Visit, at the discretion of the Investigator:
- •\[Gonococcus, chlamydia trachomatis, syphilis treponema, trichomonas vaginitis, candida vaginitis, etc.\]
- •Has vaginitis symptoms (abnormal vaginal discharge, itching, burning sensation, etc.) at Screening or pre-dose at the Day 1 visit, or between the Screening and Day 1 visits.
- •Is pregnant, lactating, within eight weeks of childbirth, or is planning pregnancy within 60 days of the last dose of IP.
- •Is menopausal, defined as being amenorrhoeic for at least 12 months without an alternative cause.
- •Has had an intrauterine device (IUD) inserted within 12 weeks before the Screening Visit
- •Underwent pelvic surgery within 12 weeks before the Screening Visit
Outcomes
Primary Outcomes
Changes in Clinical Laboratory Tests, Vital signs (body temperature, respiratory rate, heart rate, blood pressure), Gynaecological Examination, and Physical Examination.
Time Frame: Baseline and each follow-up visit upto 35 days since the first dose administration (Day 1)
Day 1 pre-dose results will be used as the baseline values. Abnormalities in clinical laboratory parameters, gynaecological examination findings, and vital signs will be based on predefined normal ranges and will be tabulated by dose group showing participant counts and percentages.
Number of AEs in participants throughout the study and their severity and relationship to the study product.
Time Frame: 35 days since the first dose administration
Any incidence of adverse events will be evaluated for their severity and relationship to the study product. The number of AEs and other combined measurement results will be evaluated for the safety of the study product.
Secondary Outcomes
- Acceptability evaluation(Visit 3 (Day 9))