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First in Human Study in Healthy Volunteers of Antimicrobial Peptide PL-18 Vaginal Suppositories
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: Female
Things to know
Study dates
Study start: 2022-08-01
Primary completion: 2023-12-04
Study completion finish: 2024-03-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05340790
Intervention or treatment
DRUG: Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
DRUG: Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
Conditions
- • Colpomycosis
- • Bacterial Vaginosis
- • Mixede Vaginitis
Find a site
Closest Location:
Q-Pharm Pty. Ltd
Research sites nearby
Select from list below to view details:
Q-Pharm Pty. Ltd
Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Antimicrobial Peptide PL-18 Vaginal Suppositories
| DRUG: Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
|
PLACEBO_COMPARATOR: Placebo dose
| DRUG: Placebo dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 17 days |
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