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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
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.
Details
| Lead sponsor | AtoGen Co. Ltd |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 24 |
| Start date | 2022-11-02 |
| Completion | 2023-05 |
Conditions
- Bacterial Vaginosis
- Vaginal Disease
- Bacterial Infections
- Vaginitis
- Infection, Bacterial
Interventions
- Experimental: Low dose LABTHERA-001 capsule
- Experimental: Medium dose LABTHERA-001 capsule
- Experimental: High dose LABTHERA-001 capsule
- Placebo Comparator: Low dose Placebo capsule
- Placebo Comparator: Medium dose Placebo capsule
- Placebo Comparator: High dose Placebo capsule
Primary outcomes
- Number of AEs in participants throughout the study and their severity and relationship to the study product. — 35 days since the first dose administration
Any incidence of adverse events will be evaluated for their severity and relationship to the study product. The number of AEs and other combined measurement results will be evaluated for the safety of the study product. - Changes in Clinical Laboratory Tests, Vital signs (body temperature, respiratory rate, heart rate, blood pressure), Gynaecological Examination, and Physical Examination. — Baseline and each follow-up visit upto 35 days since the first dose administration (Day 1)
Day 1 pre-dose results will be used as the baseline values. Abnormalities in clinical laboratory parameters, gynaecological examination findings, and vital signs will be based on predefined normal ranges and will be tabulated by dose group showing participant counts and percentages.
Countries
Australia