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

NCT ID: NCT05332340

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2022-11-30

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction; Prostate Cancer; Radical Prostatectomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Healthy Patients

Healthy patients receiving topical application of BZ371A

Group Type: EXPERIMENTAL

BZ371A

Intervention Type: DRUG

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

Interventions

BZ371A

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men or women
• Body mass index > 19 and < 28.5 Kg/m2
• Is able to understand the Informed Consent Form (ICF)

Exclusion Criteria

• Women in their menstrual period;
• Diseases that interfere with the absorption, distribution and excretion of drugs, such as history or presence of hepatic or renal diseases;
• Presence of active genital lesions or sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, Human Papillomavirus, and others) that impair analysis of local adverse effects on the genitalia;
• History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patients with heart disease (including a history of angina and/or heart failure) and nephropathies;
• Findings on ECG and/or laboratory tests that, in the investigator's judgment, are considered the research volunteer's participation or may interfere with the analysis of the study of the study;
• Blood pressure (BP) outside the limits considered safe: systolic BP (SBP) 90 - 140 mmHg and diastolic BP diastolic BP (DBP) 60 - 90 mmHg, except for situations such as "white coat syndrome";
• Any disease or condition or physical finding that the investigator considers significant and that increases the risk
• Any disease or condition or physical finding that the investigator considers significant and that increases the risk of participation of the research volunteer or may interfere with the results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azidus Brasil Scientific Research and Development Ltda

OTHER

Sponsor Role: collaborator

Biozeus Biopharmaceutical S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Regina M Doi

Role: PRINCIPAL_INVESTIGATOR

Azidus Brasil Pesquisa Científica e LTDA

Locations

Azidus Brasil Pesquisa Científica e Desenvolvimento

Valinhos, São Paulo, Brazil

Countries

Brazil

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

BZ371CLI003

Identifier Type: -

Identifier Source: org_study_id