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

PHASE1RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 1, 2022

Primary Completion Date

December 4, 2023

Study Completion Date

March 1, 2024

Conditions
ColpomycosisBacterial VaginosisMixede 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;

Trial Locations (1)

4006

RECRUITING

Q-Pharm Pty. Ltd, Brisbane

All Listed Sponsors
lead

Protelight Pharmaceuticals Australia PTY LTD

INDUSTRY