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

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Prostate Cancer; Radical Prostatectomy; Erectile Dysfunction Following Radical Prostatectomy
• Intervention / Treatment: Drug: BZ371A

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Valinhos, São Paulo, Brazil
      • Azidus Brasil Pesquisa Científica e Desenvolvimento

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Patients; Healthy patients receiving topical application of BZ371A	Drug: BZ371A; Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Peak Plasma Concentration	0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
T1/2	Terminal half-life of BZ371A	0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
AUC	Area under the curve (AUC) of plasma/serum/blood drug concentration-time curve	0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Clearance (CL)	Clearance of BZ371A	0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Vd	Distribution Volume of BZ371A	0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Physical Exam	Number of participants with abnormal physical exam findings	Baseline and 1 week
Blood Evaluation	Number of participants with abnormal laboratory test results	Baseline and 1 day
Urine Evaluation	Number of participants with abnormal urinalysis	Baseline and 1 week
Adverse Effects Evaluation	Number of Adverse Effects after compound application	All adverse effect will be collected from the beginning of the study up to one week after drug administration
Change in SBP	Number of participants with a significant change in Systolic Blood Pressure	Baseline and 1 week
Change in DBP	Number of participants with a significant change in Diastolic Blood Pressure	Baseline and 1 week
Change in Heart Rate	Change in Heart Rate (HR). The data from this measure reflect changes calculated from the baseline.	Baseline and 1 week
Change in Respiratory Rate	Change in Respiratory Rate (RR). The data from this measure reflect changes calculated from the baseline.	Baseline and 1 week
Change in Temperature	Temperature measurements. The data from this measure reflect changes calculated from the baseline.	Baseline and 1 week
Basal Chest Electrocardiogram (ECG)	Number of participants with abnormal ECG readings	Baseline and 1 week

Collaborators and Investigators

• Sponsor: Biozeus Biopharmaceutical S.A.
• Collaborators: Azidus Brasil Scientific Research and Development Ltda
• Investigators: Principal Investigator: Regina M Doi, Azidus Brasil Pesquisa Científica e LTDA

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Prostate Cancer; Radical Prostatectomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Prostatic Neoplasms; Erectile Dysfunction
• Other Study ID Numbers: BZ371CLI003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No