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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05332340
• Other study ID #: BZ371CLI003
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: Biozeus Biopharmaceutical S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy
• Prostate Cancer
• Prostatic Neoplasms
• Radical Prostatectomy

Intervention

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

Locations

Country	Name	City	State
Brazil	Azidus Brasil Pesquisa Científica e Desenvolvimento	Valinhos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Biozeus Biopharmaceutical S.A.	Azidus Brasil Scientific Research and Development Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Peak Plasma Concentration	0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Primary	T1/2	Terminal half-life of BZ371A	0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Primary	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
Primary	Clearance (CL)	Clearance of BZ371A	0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Primary	Vd	Distribution Volume of BZ371A	0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Primary	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
Primary	Physical Exam	Number of participants with abnormal physical exam findings	Baseline and 1 week
Primary	Change in SBP	Change in Systolic Blood Pressure	Baseline and 1 week
Primary	Change in DBP	Change in Diastolic Blood Pressure	Baseline and 1 week
Primary	Change in Heart Rate (HR)	Change in Heart Rate	Baseline and 1 week
Primary	Change in Respiratory Rate (RR)	Respiratory Rate	Baseline and 1 week
Primary	Change in Temperature	Temperature measurements	Baseline and 1 week
Primary	Basal chest electrocardiogram (ECG)	Number of participants with abnormal ECG readings	Baseline and 1 week
Primary	Blood Evaluation	Number of participants with abnormal laboratory test results	Baseline and 1 day
Primary	Urine Evaluation	Number of participants with abnormal urinalysis	Baseline and 1 week