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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05332340
Other study ID # BZ371CLI003
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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