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

Phase 1 Unknown 50 enrolled Protelight Pharmaceuticals Australia PTY LTD

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PL-18	Peptide	1 mg	Topical
Subject	PL-18	Peptide	2.5 mg	Topical
Subject	PL-18	Peptide	5 mg	Topical
Subject	PL-18	Peptide	10 mg	Topical
Subject	PL-18	Peptide	15 mg	Topical

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

Summary

Timeline

Drugs

Indications