Clinical trial NCT05332340: Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Erectile Dysfunction
Prostate Cancer
Radical Prostatectomy
Keywords: Erectile Dysfunction
Radical Prostatectomy
Prostate Cancer
Lead sponsor: Biozeus Biopharmaceutical S.A.
Sponsor class: INDUSTRY
Collaborators: name: Azidus Brasil Scientific Research and Development Ltda
First posted: 2022-04-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
measure: T1/2
timeFrame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
measure: AUC
timeFrame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
measure: Clearance (CL)
timeFrame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
measure: Vd
timeFrame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
measure: Adverse Effects Evaluation
timeFrame: All adverse effect will be collected from the beginning of the study up to one week after drug administration
measure: Physical Exam
timeFrame: Baseline and 1 week
measure: Change in SBP
timeFrame: Baseline and 1 week
measure: Change in DBP
timeFrame: Baseline and 1 week
measure: Change in Heart Rate
timeFrame: Baseline and 1 week
measure: Change in Respiratory Rate
timeFrame: Baseline and 1 week
measure: Change in Temperature
timeFrame: Baseline and 1 week
measure: Basal Chest Electrocardiogram (ECG)
timeFrame: Baseline and 1 week
measure: Blood Evaluation
timeFrame: Baseline and 1 day
measure: Urine Evaluation
timeFrame: Baseline and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: Azidus Brasil Pesquisa Científica e Desenvolvimento
state: São Paulo
Study officials:
affiliation: Azidus Brasil Pesquisa Científica e LTDA
name: Regina M Doi
role: PRINCIPAL_INVESTIGATOR
References: