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

NCT05340790 | Unknown Phase 1

• 1 other identifier: JSPL-PL-18-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability and PK Profiles of Single and Multiple Ascending Doses of Antimicrobial Peptide PL-18 Vaginal Suppositories.

Conditions

Colpomycosis; Bacterial Vaginosis; Mixede Vaginitis

Outcome Measures

Primary Outcomes (5)

• Characterize safety profile of Antimicrobial Peptide PL-18 Vaginal Suppositories about the incidence of treatment emergent adverse events

  All AEs will be summarized by system organ class (SOC) and preferred term (PT). The numbers and percentages of subjects experiencing AEs will be calculated.

  38 days

• The numbers and percentages of subjects experiencing vital sign abnormalities with/without clinical significance.

  Vital signs abnormalities will be summarized with descriptive statistics. Vital signs include body temperature, blood pressure, heart rate/pulse, respiration. Changes from the baseline of each test over time will be summarized.

  17 days

• The numbers and percentages of subjects experiencing physical examination abnormalities with/without clinical significance.

  Physical examinations abnormalities will be summarized with descriptive statistics. Physical examination will include general condition, skin, head, eyes, ears, nose, throat, heart, lungs, chests, abdomen, extremities, nerves, back/spine, lymph, nodes. Changes from the baseline of each test over time will be summarized.

  Day 4 , Day 11 , Day 17

• Safety assessment about the changes of clinical laboratory tests.

  Laboratory abnormalities will be summarized with descriptive statistics. Clinical laboratory tests include hematology, blood chemistry, level of immune factors, urinalysis.

  Day2, Day 4 , Day5, Day 8, Day 11 , Day 17

• Safety assessment about the changes of 12-lead ECG .

  12-lead ECG abnormalities will be summarized with descriptive statistics.

  Day1, Day 4 , Day 5, Day 7, Day 11 , Day 17

Secondary Outcomes (15)

• Maximum plasma concentration (Cmax)

  Day1~Day4

• Time to Maximum plasma concentration (Tmax)

  Day1~Day4

• Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)

  Day1~Day4

• Area under concentration-time from time zero to infinity (AUC0-inf)

  Day1~Day4

• Terminal half-life (t1/2)

  Day1~Day4

Study Arms (2)

Antimicrobial Peptide PL-18 Vaginal Suppositories

EXPERIMENTAL

Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories

Drug: Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories

Placebo dose

PLACEBO COMPARATOR

Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories

Drug: Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories

Interventions

Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories DRUG

Escalating doses of 1 mg (0.1%)、2.5mg (0.25%)、5 mg (0.5%)、10mg (1%)、15 mg (1.5%)；single dose administration；topical vaginal suppository ；multiple-dose administration after single dose administration a 3-day wash out period ; once-daily for 6 consecutive days;

Also known as: AMP PL-18

Antimicrobial Peptide PL-18 Vaginal Suppositories

Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories DRUG

Dose 1、2、3、4 and 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories respective placebos；single dose administration；topical vaginal suppository ；multiple-dose administration after single dose administration a 3-day wash out period ; once-daily for 6 consecutive days;

Also known as: Placebo PL-18

Placebo dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily signed written informed consent;
• Ability to comprehend the purpose of the study; ability to co-operate with the investigator and comply with all study requirements;
• Adult females aged between 18 and 55 years (inclusive);
• Body weight between 50 and 100 kg (inclusive) and body mass index (BMI) within 18\~32 kg/m2 (inclusive).
• In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination (including measurement of blood pressure and pulse rate), 12-lead ECG, and clinical laboratory tests:
• Vital signs (measured after resting for 5 minutes seated position) within normal range, or outside the normal range and not considered clinically significant by the Investigator;
• Standard 12-lead ECG parameters (recorded after resting for 5 minutes in supine position) in the following ranges; QTc (Fridericia algorithm recommended) ≤470 ms, and normal ECG tracing, or abnormal ECG tracing not considered clinically relevant by the Investigator;
• Laboratory parameters demonstrating no clinically significant abnormalities, as determined by the Investigator. A total bilirubin outside the normal range may be acceptable if total bilirubin does not exceed 1.5 × ULN conjugated bilirubin (with the exception of a participant with documented Gilbert syndrome).
• Self-report regular menstrual cycle (21-35 days), and planned to avoid menstruation from the first administration until 7 days after the last administration;
• Negative human papilloma virus (HPV) test result (at screening or negative HPV test result performed in study site within 2 months prior to screening;
• History of sexual life, including vaginal intercourse;
• Be willing to use vaginal suppositories;
• Currently in a mutually monogamous sexual relationship or no sexual activity;
• Sexual abstinence from 72 hours prior to the first drug administration until 7 days after the last administration;
• 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;

You may not qualify if:

• Significant deep epithelial disruption by colposcopy at screening;
• Anatomical anomalies of the genito-urinary tract and vaginal prolapse;
• Genitourinary infections at screening or within 21 days prior to screening, including but not limited to bacterial urinary tract infection, bacterial vaginosis, trichomoniasis and vulvovaginal candidiasis;
• Known, active sexually transmitted infection (STI) in partner, as per anamnesis;
• Two or more confirmed trichomoniasis, gonococcal, chlamydia trachomatis or syphilis spirochete infections within 180 days prior to screening;
• History of recurrent genital herpes or active herpes simplex virus (HSV) at screening;
• Hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), syphilis infection, or positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCVAb), HIV antibody (HIVAb), treponema pallidum antibody (TP-Ab) at screening;
• History of clinically severe relevant cardiovascular, hepatic, renal, pulmonary, gastrointestinal, endocrine, or neurological diseases that, in the investigator's opinion, may interfere with the aim of the study or affect the subject's safety;
• Uncontrolled or acute illness that may complicate the study evaluation in the investigator's opinion;
• History of hysterectomy;
• Pelvic surgery within 90 days prior to screening;
• Cervical cryotherapy or cervical laser treatment within 90 days prior to screening;
• Intrauterine device insertion or removal within 90 days prior to screening;
• Any antibiotic or antifungal therapy (intravaginal or systemic) within 30 days prior to screening;
• Immunosuppressive therapy within 60 days prior to screening;

Sponsors & Collaborators

• Protelight Pharmaceuticals Australia PTY LTD: lead

Study Sites (1)

Q-Pharm Pty. Ltd

Brisbane, Queensland, 4006, Australia

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• John McNeil, Professor

  90768825

  STUDY CHAIR

Central Study Contacts

Kristi McLendon, Dr

CONTACT

37072720; k.mclendon@nucleusnetwork.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: April 22, 2022
• Study Start: August 1, 2022
• Primary Completion: December 4, 2023
• Study Completion: March 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)