The purpose of this study is to determine the safety, local tolerability and pharmacokinetic parameters of TOL-463 intravaginal dosage forms in both healthy, nonpregnant females following single dose administration (Part 1), and in nonpregnant women with vaginitis following multi-dose administration (Part 2).
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The local (vulvovaginal) and systemic safety and tolerability of TOL-463 gel and ovules following a single intravaginal administration in healthy female subjects and following daily dosing for 7 days in women with BV or VVC will be assessed.
Timeframe: Following daily dosing for 1 or 7 days
Adverse events (AEs) will be monitored throughout the course of the study following administration of Investigational Product (IP).
Timeframe: Up to Day 16