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

NCT05340790 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-12-11

No results posted yet for this study

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

Interventions

DRUG

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;

DRUG

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;

Sponsors & Collaborators

  • Protelight Pharmaceuticals Australia PTY LTD

    lead INDUSTRY

Principal Investigators

  • John McNeil, Professor · 90768825

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-12-04
Completion
2024-03-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05340790 on ClinicalTrials.gov