First in Human Study in Healthy Volunteers of Antimicrobial Peptide PL-18 Vaginal Suppositories

Inclusion Criteria:

• A subject will be eligible for inclusion in this study only if all of the followingcriteria are met:

1. Voluntarily signed written informed consent;
2. Ability to comprehend the purpose of the study; ability to co-operate with theinvestigator and comply with all study requirements;
3. Adult females aged between 18 and 55 years (inclusive);
4. Body weight between 50 and 100 kg (inclusive) and body mass index (BMI) within 18~32 kg/m2 (inclusive).
5. In good health as determined by screening tests. Good health is defined as havingno clinically relevant abnormalities identified by a detailed medical history,full physical examination (including measurement of blood pressure and pulserate), 12-lead ECG, and clinical laboratory tests:

• Vital signs (measured after resting for 5 minutes seated position) withinnormal range, or outside the normal range and not considered clinicallysignificant by the Investigator;
• Standard 12-lead ECG parameters (recorded after resting for 5 minutes insupine position) in the following ranges; QTc (Fridericia algorithmrecommended) ≤470 ms, and normal ECG tracing, or abnormal ECG tracing notconsidered clinically relevant by the Investigator;
• Laboratory parameters demonstrating no clinically significant abnormalities,as determined by the Investigator. A total bilirubin outside the normalrange may be acceptable if total bilirubin does not exceed 1.5 × ULNconjugated bilirubin (with the exception of a participant with documentedGilbert syndrome).

6. Self-report regular menstrual cycle (21-35 days), and planned to avoidmenstruation from the first administration until 7 days after the lastadministration;
7. Negative human papilloma virus (HPV) test result (at screening or negative HPVtest result performed in study site within 2 months prior to screening;
8. History of sexual life, including vaginal intercourse;
9. Be willing to use vaginal suppositories;
10. Currently in a mutually monogamous sexual relationship or no sexual activity;
11. Sexual abstinence from 72 hours prior to the first drug administration until 7days after the last administration;
12. Agreement to avoid the use of any other intravaginal products (i.e.,contraceptive creams, gels, foams, sponges, lubricants, irrigation solutions,etc.) from screening until 7 days after the last administration;
13. Subjects in a intercourse relationship must agree to use highly effective methodsof contraception (as specified in Section 4.6.3) from informed consent obtaineduntil 3 months after the last administration, and pregnancy test results must benegative at screening.

Exclusion Criteria:

• A subject meeting any of the following exclusion criteria will not be allowed toparticipate in this study:

1. Significant deep epithelial disruption by colposcopy at screening;
2. Anatomical anomalies of the genito-urinary tract and vaginal prolapse;
3. Genitourinary infections at screening or within 21 days prior to screening,including but not limited to bacterial urinary tract infection, bacterialvaginosis, trichomoniasis and vulvovaginal candidiasis;
4. Known, active sexually transmitted infection (STI) in partner, as per anamnesis;
5. Two or more confirmed trichomoniasis, gonococcal, chlamydia trachomatis orsyphilis spirochete infections within 180 days prior to screening;
6. History of recurrent genital herpes or active herpes simplex virus (HSV) atscreening;
7. Hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV),syphilis infection, or positive hepatitis B surface antigen (HBsAg), hepatitis Bcore antibody (HBcAb), hepatitis C virus antibody (HCVAb), HIV antibody (HIVAb),treponema pallidum antibody (TP-Ab) at screening;
8. History of clinically severe relevant cardiovascular, hepatic, renal, pulmonary,gastrointestinal, endocrine, or neurological diseases that, in the investigator'sopinion, may interfere with the aim of the study or affect the subject's safety;
9. Uncontrolled or acute illness that may complicate the study evaluation in theinvestigator's opinion;
10. History of hysterectomy;
11. Pelvic surgery within 90 days prior to screening;
12. Cervical cryotherapy or cervical laser treatment within 90 days prior toscreening;
13. Intrauterine device insertion or removal within 90 days prior to screening;
14. Any antibiotic or antifungal therapy (intravaginal or systemic) within 30 daysprior to screening;
15. Immunosuppressive therapy within 60 days prior to screening;
16. Ascertained or presumptive hypersensitivity (including allergies) to anyingredient of the investigational medicinal product (IMP); history of othersignificant anaphylaxis to drugs or allergic reactions in general;
17. Pregnant or lactating women, or women within 60 days of the last pregnancy;
18. Subjects who consume or are unable to abstain from products containingcaffeine/xanthine within 24 hours before a visit or admission;
19. History of drug or alcohol abuse within 1year prior to screening, or a positiveresult of drug abuse or alcohol breath test at screening or check-in;
20. Previously dosed with an investigational drug within 3 months prior to Day 1 orstill participating in another trial at the time of screening;
21. Any vaccination from the 28 days prior to administration of the first dose until 28 days after the last dose;
22. Those considered by the investigator as inappropriate to participate in thestudy.