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

Primary Purpose

Colpomycosis, Bacterial Vaginosis, Mixede Vaginitis

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
Sponsored by
Protelight Pharmaceuticals Australia PTY LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colpomycosis

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

    1. Voluntarily signed written informed consent;
    2. Ability to comprehend the purpose of the study; ability to co-operate with the investigator 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 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).
    6. Self-report regular menstrual cycle (21-35 days), and planned to avoid menstruation from the first administration until 7 days after the last administration;
    7. Negative human papilloma virus (HPV) test result (at screening or negative HPV test 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 7 days 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 methods of contraception (as specified in Section 4.6.3) from informed consent obtained until 3 months after the last administration, and pregnancy test results must be negative at screening.

Exclusion Criteria:

  • A subject meeting any of the following exclusion criteria will not be allowed to participate 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, bacterial vaginosis, 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 or syphilis spirochete infections within 180 days prior to screening;
    6. History of recurrent genital herpes or active herpes simplex virus (HSV) at screening;
    7. 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;
    8. 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;
    9. Uncontrolled or acute illness that may complicate the study evaluation in the investigator'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 to screening;
    13. Intrauterine device insertion or removal within 90 days prior to screening;
    14. Any antibiotic or antifungal therapy (intravaginal or systemic) within 30 days prior to screening;
    15. Immunosuppressive therapy within 60 days prior to screening;
    16. Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the investigational medicinal product (IMP); history of other significant 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 containing caffeine/xanthine within 24 hours before a visit or admission;
    19. History of drug or alcohol abuse within 1year prior to screening, or a positive result 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 or still 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 the study.

Sites / Locations

  • Q-Pharm Pty. LtdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Antimicrobial Peptide PL-18 Vaginal Suppositories

Placebo dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Safety assessment about the changes of 12-lead ECG .
12-lead ECG abnormalities will be summarized with descriptive statistics.

Secondary Outcome Measures

Maximum plasma concentration (Cmax)
Concentrations of Antimicrobial Peptide PL-18 in Plasma samples at different time points are measured.Maximum plasma concentration (Cmax) is a PK parameter of the single-dose stage.Plasma concentrations at different time points will be listed and summarized by descriptive statistics.
Time to Maximum plasma concentration (Tmax)
Tmax is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)
AUC0-t is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Area under concentration-time from time zero to infinity (AUC0-inf)
AUC0-t is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Terminal half-life (t1/2)
t1/2 is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Apparent clearance (CL/F)
CL/F is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Apparent volume of distribution (Vz/F)
Vz/F is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Mean residence time (MRT)
MRT is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Terminal elimination rate constant (λz)
λz is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Maximum observed concentration at steady state (Cmax,ss)
Concentrations of Antimicrobial Peptide PL-18 in Plasma samples at different time points are measured.Maximum observed concentration at steady state (Cmax,ss) is a PK parameter of the multi-dose stage.
Minimum observed concentration at steady state (Cmin,ss)
Concentrations of Antimicrobial Peptide PL-18 in Plasma samples at different time points are measured. Minimum observed concentration at steady state (Cmin,ss) is a PK parameter of the multi-dose stage.
The average concentration during a dosing interval at steady state (Cav,ss)
The average concentration during a dosing interval at steady state (Cav,ss) is a PK parameter of the multi-dose stage. Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
AUCss is a PK parameter of the multi-dose stage. Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Accumulation ratio (Rac)
Accumulation ratio (Rac) is a PK parameter of the multi-dose stage. Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Characterize the effect of Antimicrobial peptide PL-18 Vaginal Suppositories on vaginal bacteria
Changes in vaginal bacteria after single and multiple doses of Antimicrobial Peptide PL-18 Vaginal Suppositories in healthy adult female subjects assessed. Changes in vaginal bacteria will be summarized with descriptive statistics.

Full Information

First Posted
February 23, 2022
Last Updated
October 13, 2022
Sponsor
Protelight Pharmaceuticals Australia PTY LTD
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1. Study Identification

Unique Protocol Identification Number
NCT05340790
Brief Title
First in Human Study in Healthy Volunteers of Antimicrobial Peptide PL-18 Vaginal Suppositories
Official Title
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Antimicrobial Peptide PL-18 Vaginal Suppositories in Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Protelight Pharmaceuticals Australia PTY LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colpomycosis, Bacterial Vaginosis, Mixede Vaginitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antimicrobial Peptide PL-18 Vaginal Suppositories
Arm Type
Experimental
Arm Description
Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
Arm Title
Placebo dose
Arm Type
Placebo Comparator
Arm Description
Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
Intervention Type
Drug
Intervention Name(s)
Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
Intervention Description
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;
Primary Outcome Measure Information:
Title
Characterize safety profile of Antimicrobial Peptide PL-18 Vaginal Suppositories about the incidence of treatment emergent adverse events
Description
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.
Time Frame
38 days
Title
The numbers and percentages of subjects experiencing vital sign abnormalities with/without clinical significance.
Description
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.
Time Frame
17 days
Title
The numbers and percentages of subjects experiencing physical examination abnormalities with/without clinical significance.
Description
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.
Time Frame
Day 4 , Day 11 , Day 17
Title
Safety assessment about the changes of clinical laboratory tests.
Description
Laboratory abnormalities will be summarized with descriptive statistics. Clinical laboratory tests include hematology, blood chemistry, level of immune factors, urinalysis.
Time Frame
Day2, Day 4 , Day5, Day 8, Day 11 , Day 17
Title
Safety assessment about the changes of 12-lead ECG .
Description
12-lead ECG abnormalities will be summarized with descriptive statistics.
Time Frame
Day1, Day 4 , Day 5, Day 7, Day 11 , Day 17
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Description
Concentrations of Antimicrobial Peptide PL-18 in Plasma samples at different time points are measured.Maximum plasma concentration (Cmax) is a PK parameter of the single-dose stage.Plasma concentrations at different time points will be listed and summarized by descriptive statistics.
Time Frame
Day1~Day4
Title
Time to Maximum plasma concentration (Tmax)
Description
Tmax is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day1~Day4
Title
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)
Description
AUC0-t is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day1~Day4
Title
Area under concentration-time from time zero to infinity (AUC0-inf)
Description
AUC0-t is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day1~Day4
Title
Terminal half-life (t1/2)
Description
t1/2 is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day1~Day4
Title
Apparent clearance (CL/F)
Description
CL/F is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day1~Day4
Title
Apparent volume of distribution (Vz/F)
Description
Vz/F is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day1~Day4
Title
Mean residence time (MRT)
Description
MRT is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day1~Day4
Title
Terminal elimination rate constant (λz)
Description
λz is a PK parameter of the single-dose stage.Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day1~Day4
Title
Maximum observed concentration at steady state (Cmax,ss)
Description
Concentrations of Antimicrobial Peptide PL-18 in Plasma samples at different time points are measured.Maximum observed concentration at steady state (Cmax,ss) is a PK parameter of the multi-dose stage.
Time Frame
Day5~Day 11
Title
Minimum observed concentration at steady state (Cmin,ss)
Description
Concentrations of Antimicrobial Peptide PL-18 in Plasma samples at different time points are measured. Minimum observed concentration at steady state (Cmin,ss) is a PK parameter of the multi-dose stage.
Time Frame
Day5~Day 11
Title
The average concentration during a dosing interval at steady state (Cav,ss)
Description
The average concentration during a dosing interval at steady state (Cav,ss) is a PK parameter of the multi-dose stage. Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day5~Day 11
Title
Area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Description
AUCss is a PK parameter of the multi-dose stage. Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day5~Day 11
Title
Accumulation ratio (Rac)
Description
Accumulation ratio (Rac) is a PK parameter of the multi-dose stage. Plasma PK parameters will be analyzed by non-compartmental analysis (NCA) with WinNonlin® version 8.1 or above and SAS® version 9.4 or higher.
Time Frame
Day5~Day 11
Title
Characterize the effect of Antimicrobial peptide PL-18 Vaginal Suppositories on vaginal bacteria
Description
Changes in vaginal bacteria after single and multiple doses of Antimicrobial Peptide PL-18 Vaginal Suppositories in healthy adult female subjects assessed. Changes in vaginal bacteria will be summarized with descriptive statistics.
Time Frame
17 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria are met: 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; Subjects in a intercourse relationship must agree to use highly effective methods of contraception (as specified in Section 4.6.3) from informed consent obtained until 3 months after the last administration, and pregnancy test results must be negative at screening. Exclusion Criteria: A subject meeting any of the following exclusion criteria will not be allowed to participate in this study: 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; Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the investigational medicinal product (IMP); history of other significant anaphylaxis to drugs or allergic reactions in general; Pregnant or lactating women, or women within 60 days of the last pregnancy; Subjects who consume or are unable to abstain from products containing caffeine/xanthine within 24 hours before a visit or admission; History of drug or alcohol abuse within 1year prior to screening, or a positive result of drug abuse or alcohol breath test at screening or check-in; Previously dosed with an investigational drug within 3 months prior to Day 1 or still participating in another trial at the time of screening; Any vaccination from the 28 days prior to administration of the first dose until 28 days after the last dose; Those considered by the investigator as inappropriate to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristi McLendon, Dr
Phone
37072720
Email
k.mclendon@nucleusnetwork.com.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McNeil, Professor
Organizational Affiliation
90768825
Official's Role
Study Chair
Facility Information:
Facility Name
Q-Pharm Pty. Ltd
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristi McLendon, Dr
Phone
37072720
Email
K.mclendon@nucleusnetwork.com.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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