ColpomycosisPhase 1NCT05340790
First in Human Study in Healthy Volunteers of Antimicrobial Peptide PL-18 Vaginal Suppositories
A Phase 1 study testing Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories in people with Colpomycosis and Bacterial Vaginosis, run by Protelight Pharmaceuticals Australia PTY LTD at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colpomycosis, Bacterial Vaginosis, Mixede Vaginitis
- What is being tested?
- Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Aug 2022to 1 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Q-Pharm Pty. Ltd
Brisbane, Queensland, 4006
Kristi McLendon, Dr, 37072720, K.mclendon@nucleusnetwork.com.au
About this study
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
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.
Read the detailed description
Subjects who provide written informed consent to participate voluntarily in the clinical study will be screened. Eligible subjects will be sequentially enrolled into the above five sequential cohorts and randomized to receive PL-18 (cohort 1: n=8; cohort 2/3/4/5: n=6) or matching placebo (n=2). Subjects will be observed for 3 days after a single dose and receive PL-18 or placebo, once daily, for 6 consecutive days, if no grade ≥2 drug-related adverse events (AEs) occur. During the study, PK sample collection, physical examination, vital signs, laboratory tests, electrocardiography (ECG) and tolerance evaluation will be performed based on the protocol schedule.
To ensure the safety of the subjects, two sentinel subjects will be enrolled first in each cohort; one subject will be randomized to receive PL-18, and the other subject randomized to receive placebo. The safety data of the two sentinel subjects from initiation of single dosing to the last drug administration of multiple dosing on D11 will be reviewed by the investigator and sponsor before the subsequent subjects in that dose cohort are enrolled. Subsequent subjects could be simultaneously enrolled, with one randomized to receive placebo and others randomized to receive PL-18.
- Conditions
- Colpomycosis, Bacterial Vaginosis, Mixede Vaginitis
- Being tested
- Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories, Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal SuppositoriesDrug
Also called AMP PL-18
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;
Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal SuppositoriesDrug
Also called Placebo PL-18
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;
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial Peptide PL-18 Vaginal Suppositories | Experimental | Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories Receives: 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 Receives: Drug: Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day1, Day 4 , Day 5, Day 7, Day 11 , Day 17
Secondary outcomes (15)
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.
Measured: Day1~Day4
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.
Measured: Day1~Day4
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.
Measured: Day1~Day4
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.
Measured: Day1~Day4
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.
Measured: Day1~Day4
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.
Measured: Day1~Day4
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.
Measured: Day1~Day4
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.
Measured: Day1~Day4
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.
Measured: Day1~Day4
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.
Measured: Day5~Day 11
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.
Measured: Day5~Day 11
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.
Measured: Day5~Day 11
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.
Measured: Day5~Day 11
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.
Measured: Day5~Day 11
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.
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Aug 2022
- Primary completion4 Dec 2023
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColpomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Protelight Pharmaceuticals Australia PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McNeil, Professor, Study chair, 90768825
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340790
- Sponsor's protocol ID
- JSPL-PL-18-101
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05340790
- Acronym / sponsor ID
- JSPL-PL-18-101
- Conditions
- Colpomycosis, Bacterial Vaginosis, Mixede Vaginitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Protelight Pharmaceuticals Australia PTY LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects who provide written informed consent to participate voluntarily in the clinical study will be screened. Eligible subjects will be sequentially enrolled into the above five sequential cohorts and randomized to receive PL-18 (cohort 1: n=8; cohort 2/3/4/5: n=6) or matching placebo (n=2). Subjects will be observed for 3 days after a single dose and receive PL-18 or placebo, once daily, for 6 consecutive days, if no grade ≥2 drug-related adverse events (AEs) occur. During the study, PK sample collection, physical examination, vital signs, laboratory tests, electrocardiography (ECG) and tolerance evaluation will be performed based on the protocol schedule.
To ensure the safety of the subjects, two sentinel subjects will be enrolled first in each cohort; one subject will be randomized to receive PL-18, and the other subject randomized to receive placebo. The safety data of the two sentinel subjects from initiation of single dosing to the last drug administration of multiple dosing on D11 will be reviewed by the investigator and sponsor before the subsequent subjects in that dose cohort are enrolled. Subsequent subjects could be simultaneously enrolled, with one randomized to receive placebo and others randomized to receive PL-18.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial Peptide PL-18 Vaginal Suppositories | Experimental | Drug: Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal SuppositoriesDose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories |
| Placebo dose | Placebo comparator | Drug: Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal SuppositoriesPlacebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria are met:
Key exclusion criteria (23 listed)
- A subject meeting any of the following exclusion criteria will not be allowed to participate in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal SuppositoriesAlso: AMP PL-18Escalating 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; | Drug | Antimicrobial Peptide PL-18 Vaginal Suppositories |
| Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal SuppositoriesAlso: Placebo PL-18Dose 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; | Drug | Placebo dose |
Primary outcome
Characterize safety profile of Antimicrobial Peptide PL-18 Vaginal Suppositories about the incidence of treatment emergent adverse events
Time frame: 38 days
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.
Time frame: 17 days
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.
Time frame: Day 4 , Day 11 , Day 17
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.
Time frame: Day2, Day 4 , Day5, Day 8, Day 11 , Day 17
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 .
Time frame: Day1, Day 4 , Day 5, Day 7, Day 11 , Day 17
12-lead ECG abnormalities will be summarized with descriptive statistics.
15 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Day1~Day4
Time to Maximum plasma concentration (Tmax)
Time frame: Day1~Day4
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)
Time frame: Day1~Day4
Area under concentration-time from time zero to infinity (AUC0-inf)
Time frame: Day1~Day4
Terminal half-life (t1/2)
Time frame: Day1~Day4
Apparent clearance (CL/F)
Time frame: Day1~Day4
Apparent volume of distribution (Vz/F)
Time frame: Day1~Day4
Mean residence time (MRT)
Time frame: Day1~Day4
Terminal elimination rate constant (λz)
Time frame: Day1~Day4
Maximum observed concentration at steady state (Cmax,ss)
Time frame: Day5~Day 11
Minimum observed concentration at steady state (Cmin,ss)
Time frame: Day5~Day 11
The average concentration during a dosing interval at steady state (Cav,ss)
Time frame: Day5~Day 11
Area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Time frame: Day5~Day 11
Accumulation ratio (Rac)
Time frame: Day5~Day 11
Characterize the effect of Antimicrobial peptide PL-18 Vaginal Suppositories on vaginal bacteria
Time frame: 17 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John McNeil, Professor study chair
90768825
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories in people with Colpomycosis and Bacterial Vaginosis, run by Protelight Pharmaceuticals Australia PTY LTD at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristi McLendon, Dr (37072720, k.mclendon@nucleusnetwork.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize safety profile of Antimicrobial Peptide PL-18 Vaginal Suppositories about the incidence of treatment emergent adverse events (time frame: 38 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.