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

Phase 1

Completed

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

Interventions: Drug: BZ371A

Registration Number: NCT05332340

Lead Sponsor: Biozeus Biopharmaceutical S.A.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Patients	BZ371A	Healthy patients receiving topical application of BZ371A

Primary Outcome Measures

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