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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05340790




Registration number
NCT05340790
Ethics application status
Date submitted
23/02/2022
Date registered
22/04/2022

Titles & IDs
Public title
First in Human Study in Healthy Volunteers of Antimicrobial Peptide PL-18 Vaginal Suppositories
Scientific 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
Secondary ID [1] 0 0
JSPL-PL-18-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colpomycosis 0 0
Bacterial Vaginosis 0 0
Mixede Vaginitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
Treatment: Drugs - Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories

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

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


Treatment: Drugs: Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
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;

Treatment: Drugs: Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
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;
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Characterize safety profile of Antimicrobial Peptide PL-18 Vaginal Suppositories about the incidence of treatment emergent adverse events
Timepoint [1] 0 0
38 days
Primary outcome [2] 0 0
The numbers and percentages of subjects experiencing vital sign abnormalities with/without clinical significance.
Timepoint [2] 0 0
17 days
Primary outcome [3] 0 0
The numbers and percentages of subjects experiencing physical examination abnormalities with/without clinical significance.
Timepoint [3] 0 0
Day 4 , Day 11 , Day 17
Primary outcome [4] 0 0
Safety assessment about the changes of clinical laboratory tests.
Timepoint [4] 0 0
Day2, Day 4 , Day5, Day 8, Day 11 , Day 17
Primary outcome [5] 0 0
Safety assessment about the changes of 12-lead ECG .
Timepoint [5] 0 0
Day1, Day 4 , Day 5, Day 7, Day 11 , Day 17
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Day1~Day4
Secondary outcome [2] 0 0
Time to Maximum plasma concentration (Tmax)
Timepoint [2] 0 0
Day1~Day4
Secondary outcome [3] 0 0
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)
Timepoint [3] 0 0
Day1~Day4
Secondary outcome [4] 0 0
Area under concentration-time from time zero to infinity (AUC0-inf)
Timepoint [4] 0 0
Day1~Day4
Secondary outcome [5] 0 0
Terminal half-life (t1/2)
Timepoint [5] 0 0
Day1~Day4
Secondary outcome [6] 0 0
Apparent clearance (CL/F)
Timepoint [6] 0 0
Day1~Day4
Secondary outcome [7] 0 0
Apparent volume of distribution (Vz/F)
Timepoint [7] 0 0
Day1~Day4
Secondary outcome [8] 0 0
Mean residence time (MRT)
Timepoint [8] 0 0
Day1~Day4
Secondary outcome [9] 0 0
Terminal elimination rate constant (?z)
Timepoint [9] 0 0
Day1~Day4
Secondary outcome [10] 0 0
Maximum observed concentration at steady state (Cmax,ss)
Timepoint [10] 0 0
Day5~Day 11
Secondary outcome [11] 0 0
Minimum observed concentration at steady state (Cmin,ss)
Timepoint [11] 0 0
Day5~Day 11
Secondary outcome [12] 0 0
The average concentration during a dosing interval at steady state (Cav,ss)
Timepoint [12] 0 0
Day5~Day 11
Secondary outcome [13] 0 0
Area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Timepoint [13] 0 0
Day5~Day 11
Secondary outcome [14] 0 0
Accumulation ratio (Rac)
Timepoint [14] 0 0
Day5~Day 11
Secondary outcome [15] 0 0
Characterize the effect of Antimicrobial peptide PL-18 Vaginal Suppositories on vaginal bacteria
Timepoint [15] 0 0
17 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty. Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Protelight Pharmaceuticals Australia PTY LTD
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John McNeil, Professor
Address 0 0
90768825
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kristi McLendon, Dr
Address 0 0
Country 0 0
Phone 0 0
37072720
Fax 0 0
Email 0 0
k.mclendon@nucleusnetwork.com.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05340790