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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• ATOGEN AUSTRALIA PTY LTD

  collaborator UNKNOWN

• AtoGen Co. Ltd

  lead INDUSTRY

Principal Investigators

• Christopher Argent, Dr. · Scientia Clinical Research Ltd

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-11-02

Primary Completion

2023-04-30

Completion

2023-05-31

Countries

• Australia

Study Locations