Spots Global Cancer Trial Database for Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered

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Trial Identification

Brief Title: Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered

Official Title: Phase 1 Clinical Trial Study to Evaluate Pharmacokinetics and Safety Profile of BZ371A in a Gel Formulation, Applied on Healthy Men and Women Genitals

Study ID: NCT05332340

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Erectile Dysfunction

Prostate Cancer

Radical Prostatectomy

Interventions

BZ371A

Study Description

Brief Summary: The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.

Detailed Description: Prostate cancer remains one of the most prevalent cancer in men. For its treatment, recent technological advances demonstrate that the most effective treatment is the Radical Prostatectomy (RP) procedure. However, although curative for Prostate Cancer, can result in damage to the cavernosal nerves. The cavernosal autonomic nerves travel posterolaterally to the prostate to enter the penis and regulate blood flow and hence erection. Thus, damage caused by RP will affect NO tissue release and blood flow regulation, causing erectile dysfunction. BZ371A has the ability to restore local blood flow regulation by a new and innovative mechanism of action and, therefore, has potential to be a supportive therapy for RP patients (restoring the erectile function). Thus, this study has the purpose to evaluate safety, tolerability and pharmacokinetics of a BZ371A single dose, topically administrated at the genital area.