Clinical Trials Directory

Trials / Completed

CompletedNCT05332340

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Biozeus Biopharmaceutical S.A. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGBZ371ASingle dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.

Timeline

Start date
2022-11-16
Primary completion
2022-11-30
Completion
2022-11-30
First posted
2022-04-18
Last updated
2025-03-07
Results posted
2025-03-07

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT05332340. Inclusion in this directory is not an endorsement.