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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 being developed for the treatment of bacterial vaginosis, a common vaginal infection. It is currently in Phase 1 clinical development and has not yet been approved by regulatory authorities.
DARE-BV1 is being developed by Dare Bioscience, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DARE. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug.
DARE-BV1 is in Phase 1 clinical development. A Phase 1 pharmacokinetic study has been completed, and the drug remains investigational. It has not received FDA approval and is not yet available for commercial use.
DARE-BV1 has one completed clinical trial, NCT05354050, titled "Pharmacokinetic Study of DARE-BV1." This Phase 1 study enrolled 21 female participants in the United States and evaluated the drug's pharmacokinetics in healthy volunteers.
DARE-BV1 is a distinct investigational small molecule being developed specifically for bacterial vaginosis. It is not known to be the same as any other marketed or investigational drug. Its mechanism of action has not been disclosed in available information.