Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women

Bacterial Infections Clinical Trial

Official title: Phase 1 Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Clinical Trial to Evaluate the Safety, Tolerability and Acceptability of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Female Volunteers

Status Recruiting

Clinical Trial Summary

This is a phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled, dose escalation, clinical trial enrolling 24 healthy participants. The main subject is to investigate the safety and tolerability of the LABTHERA-001 capsule and to explore the acceptability of the capsule.

Clinical Trial Description

Bacterial vaginosis (BV) is the most common vaginal syndrome frequently found in women. BV is currently mainly treated with antibiotics. However, antibiotic administration can cause various side effects. And one of them is destroying the normal bacteria in the vagina, affecting the balance of the vaginal flora, increasing the likelihood of bacterial vaginosis recurrence, and causing drug resistance of bacteria. Therefore, the importance of fundamental treatment with the recovery of balance in normal vaginal flora is being recognized increasingly. The study drug for this trial, LABTHERA-001, has been derived from the bacteria Lactobacillus plantarum ATG-K2. Administration of the ATG-K2 strain will temporarily colonize the vagina to encourage a more normal microbiome.

The main goals of this study are 1. to determine whether LABTHERA-001 is safe and well tolerated in healthy adult women. And 2. to investigate the acceptability of the LABTHERA-001 capsule or matching placebo by completing a satisfaction evaluation questionnaire. ;

Related Conditions & MeSH terms

• Bacterial Infections
• Bacterial Vaginosis
• Communicable Diseases
• Infection, Bacterial
• Infections
• Vaginal Disease
• Vaginal Diseases
• Vaginitis
• Vaginosis, Bacterial

• NCT number: NCT05587283
• Study type: Interventional
• Source: AtoGen Co. Ltd
• Contact: Scientia Clinical Research Study Team
• Phone: +61 02 9382 5800
• Email: christopher.argent@scientiaclinicalresearch.com.au
• Status: Recruiting
• Phase: Phase 1
• Start date: November 2, 2022
• Completion date: May 2023