NCT05587283

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

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: AtoGen Co. Ltd · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Experimental: Low dose LABTHERA-001 capsule	Low dose LABTHERA-001 capsule, 0.2 x 10\^9 CFU/capsule with excipients.
DRUG	Experimental: Medium dose LABTHERA-001 capsule	Medium dose LABTHERA-001 capsule, 1 x 10\^9 CFU/capsule with excipients.
DRUG	Experimental: High dose LABTHERA-001 capsule	High dose LABTHERA-001 capsule, 5 x 10\^9 CFU/capsule with excipients.
OTHER	Placebo Comparator: Low dose Placebo capsule	Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
OTHER	Placebo Comparator: Medium dose Placebo capsule	Medium dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.
OTHER	Placebo Comparator: High dose Placebo capsule	High dose Placebo capsule, filled with excipients; Lactose, and magnesium stearate.

Timeline

• Start date: 2022-11-02
• Primary completion: 2023-04-01
• Completion: 2023-05-01
• First posted: 2022-10-20
• Last updated: 2023-03-09

Locations

1 site across 1 country: Australia