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

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

Detailed Description
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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.

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

Conditions
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Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer, Radical Prostatectomy

Intervention / Treatment
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* Drug: BZ371A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 
| Adverse Effects Evaluation | Adverse effect evaluation of compound use and application | All adverse effect will be collected from the beginning of the study up to one week after drug administration | 
| Physical Exam | Number of participants with abnormal physical exam findings | Baseline and 1 week | 
| Change in SBP | Change in Systolic Blood Pressure | Baseline and 1 week | 
| Change in DBP | Change in Diastolic Blood Pressure | Baseline and 1 week | 
| Change in Heart Rate (HR) | Change in Heart Rate | Baseline and 1 week | 
| Change in Respiratory Rate (RR) | Respiratory Rate | Baseline and 1 week | 
| Change in Temperature | Temperature measurements | Baseline and 1 week | 
| Basal chest electrocardiogram (ECG) | Number of participants with abnormal ECG readings | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction, Radical Prostatectomy, Prostate Cancer