Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women

Inclusion Criteria:

1. Healthy non-smoking woman aged 18 to 45 years old as of the date of written consent
2. Agrees to maintain her contraceptive method during the clinical trial if she hasregular menstrual cycles (21-35 days) or has had amenorrhea for more than 12 weeksbefore the Screening Visit due to continued use of long-acting progestin or oralcontraceptives.
3. Confirmed normal cervical screen test (CST) performed at the Screening Visit
4. Has had sexual experiences that included vaginal intercourse
5. Has experienced gynecological examinations previously
6. 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.)

7. Agrees to be sexually abstinent from 72 hours before the Day 1 visit until the firststudy visit after final administration of IP (nominally the Day 9 visit).
8. Agrees to continue to use the following highly effective contraceptive methods duringthe clinical trial period and for at least 30 days after the final dose of studytreatment, if woman of child-bearing potential (has experienced menarche and is notpermanently sterile or postmenopausal):

• Female: combined (estrogen and progestogen containing) hormonal/ contraceptionassociated with inhibition of ovulation (oral or transdermal), progestogen-onlyhormonal contraception associated with inhibition of ovulation (oral, injectable,implantable), intrauterine device (IUD; if inserted more than 12 weeks before theScreening visit), intrauterine hormone-releasing system (IUS), bilateral tubalocclusion, vasectomized partner, sexual abstinence
• Male partner: 'Vasectomy,' 'condom'

9. Able and willing to insert a hard capsule into her vagina
10. Able and willing to answer questions about her health status and sexual life
11. Able and willing to undergo vaginal and cervical examinations by the Investigator
12. Agrees and can comply with the planned clinical trial procedures after receiving afull explanation and voluntarily decides to participate and gives written informedconsent

Exclusion Criteria:

1. Confirmed to have the following urogenital infections from the vaginal discharge testperformed at the Screening Visit, or had the following diagnosed urogenital infectionswithin three weeks before the Screening Visit, or has a history of clinicallysignificant urogenital infections at the discretion of the Investigator: • Urinary tract infection, bacterial vaginosis, candida vaginitis, trichomonasvaginalis, Neisseria gonorrhoeae, chlamydia trachomatis, treponema pallidum, herpessimplex
2. History of recurrent genital herpes
3. Has the following diagnosed urogenital infections, or had two or more clinicallysignificant urogenital infections within 24 weeks before the Screening Visit, at thediscretion of the Investigator: • [Gonococcus, chlamydia trachomatis, syphilis treponema, trichomonas vaginitis,candida vaginitis, etc.]
4. 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 1visits.
5. Is pregnant, lactating, within eight weeks of childbirth, or is planning pregnancywithin 60 days of the last dose of IP.
6. Is menopausal, defined as being amenorrhoeic for at least 12 months without analternative cause.
7. Has had an intrauterine device (IUD) inserted within 12 weeks before the ScreeningVisit
8. Underwent pelvic surgery within 12 weeks before the Screening Visit
9. Received cervical cryotherapy or cervical laser treatment within 12 weeks before theScreening Visit
10. Started to use long-acting hormonal contraceptives within 12 weeks before theScreening Visit [e.g., DMPA (depot formulation including medroxyprogesterone acetate)] (However, participants who have continuously used the contraceptive for more than 12weeks can be enrolled at the discretion of the Investigator.)
11. Has a clinically significant medical history or current medical condition as assessedby the Investigator including but not limited to the cardiovascular system,respiratory system, kidney, endocrine system, hematology, digestive system, centralnervous system, psychiatric disorder, or infectious disease, that may affect thesafety evaluation of the investigational product or jeopardize the individual'sinvolvement in the study. History of any cancer (including non-melanoma skin cancer)is exclusionary.
12. Positive test for SARS-CoV-2 (COVID-19) during the Screening period and pre-dose atthe Day 1 visit (may be re-screened when eligible).
13. Positive diagnosis of human immunodeficiency virus (HIV), hepatitis B or C at theScreening Visit
14. Confirmed to have severe damage to the vaginal epithelium in the physical examinationat the Screening Visit
15. Used immunosuppressants within four weeks before the Screening Visit
16. Used antibiotics or antifungals within three days before the Screening Visit (However,enrollment is possible if the individual agrees to a washout period equivalent tothree times or more the half-life of the corresponding drugs as of the randomizationdate.)
17. History of hypersensitivity reactions to the components of the study drug or historyof other serious drug hypersensitivity reactions, at the discretion of theInvestigator
18. History of or current drug or alcohol abuse; or tests positive to urine drug screen oralcohol breath test at the Screening or Day 1 visits; or does not agree to abstainfrom alcohol 24 hours before each study visit and to consume no more than 10 standarddrinks per week with no more than 4 standard drinks on any one day at any other timeduring their participation in the study. One standard drink contains 10 g alcohol.Urine drug screen may be repeated once only at the discretion of the Investigator.
19. Current tobacco smoker; or smoked more than one pack of cigarettes (or tobaccoequivalent) per day for more than 10 years; or uses nicotine-replacement therapy (including vaping); or does not agree to abstain from using tobacco ornicotine-containing products during the study.
20. Received other investigational products within four weeks before the Screening Visit
21. Received COVID-19 vaccination or any other vaccination within 8 weeks before the firstdose of IP, and/or is planning or scheduled to be vaccinated (including COVID-19initial, second or booster dose) during the study period up to the final follow-upvisit.
22. Judged by the Investigator to be unsuitable for participation in this clinical trial.