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DARE-BV1 · 1 trial · 1 indication
Evaluate the PK of a single dose of DARE-BV1 in healthy female subjects by assessment of plasma and vaginal clindamycin concentrations
| Arm | Type | Description |
|---|---|---|
| DARE-BV1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DARE-BV1 | DRUG | 2% Clindamycin 100 MG |
Inclusion Criteria: 1. Subjects must be females \>= 18 years of age with no known medical conditions that, in the Investigator's opinion, may interfere with study participation. 2. Subjects may engage in heterosexual intercourse between Screening and Day-1, but must agree to abstain from sexual int...
DARE-BV1 is an investigational small molecule therapeutic being developed by Dare Bioscience, Inc. for the treatment of bacterial vaginosis, a common vaginal infection. It is in Phase 1 clinical development and has been studied in a single completed pharmacokinetic trial conducted in the United States.
DARE-BV1 is being developed for the treatment of bacterial vaginosis, an infectious disease of the vaginal tract. Its development program is focused on this indication, and it has been evaluated in a Phase 1 pharmacokinetic study in adult women with bacterial vaginosis.
DARE-BV1 is being developed by Dare Bioscience, Inc., a biopharmaceutical company that trades under the ticker symbol DARE. Dare Bioscience is the sponsor of the clinical program evaluating DARE-BV1 for bacterial vaginosis.
DARE-BV1 is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program's only listed trial, a Phase 1 pharmacokinetic study, has been completed, and no trials are currently active.
DARE-BV1 has been studied in one completed clinical trial, NCT05354050, titled a Pharmacokinetic Study of DARE-BV1. The Phase 1 trial enrolled 21 participants in the United States, included females aged 18 years and older, and permitted healthy volunteers. It was an uncontrolled study without randomization or blinding.