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Completed

NCT Number: NCT05332340

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

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

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Key information

Conditions

Erectile Dysfunction Following Radical Prostatectomy Erectile Dysfunction Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Radical Prostatectomy Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Azidus Brasil Pesquisa Científica e Desenvolvimento

Valinhos, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BZ371A

Drug

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

Primary outcomes

  1. Cmax

    Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose

    Peak Plasma Concentration

  2. T1/2

    Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose

    Terminal half-life of BZ371A

  3. AUC

    Time frame: 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

  4. Clearance (CL)

    Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose

    Clearance of BZ371A

  5. Vd

    Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose

    Distribution Volume of BZ371A

  6. Adverse Effects Evaluation

    Time frame: 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

  7. Physical Exam

    Time frame: Baseline and 1 week

    Number of participants with abnormal physical exam findings

  8. Change in SBP

    Time frame: Baseline and 1 week

    Number of participants with a significant change in Systolic Blood Pressure

  9. Change in DBP

    Time frame: Baseline and 1 week

    Number of participants with a significant change in Diastolic Blood Pressure

  10. Change in Heart Rate

    Time frame: Baseline and 1 week

    Change in Heart Rate (HR).

    The data from this measure reflect changes calculated from the baseline.

  11. Change in Respiratory Rate

    Time frame: Baseline and 1 week

    Change in Respiratory Rate (RR).

    The data from this measure reflect changes calculated from the baseline.

  12. Change in Temperature

    Time frame: Baseline and 1 week

    Temperature measurements.

    The data from this measure reflect changes calculated from the baseline.

  13. Basal Chest Electrocardiogram (ECG)

    Time frame: Baseline and 1 week

    Number of participants with abnormal ECG readings

  14. Blood Evaluation

    Time frame: Baseline and 1 day

    Number of participants with abnormal laboratory test results

  15. Urine Evaluation

    Time frame: Baseline and 1 week

    Number of participants with abnormal urinalysis

Sponsors and collaborators

Lead sponsor

Biozeus Biopharmaceutical S.A.

Industry

Collaborators

  • Azidus Brasil Scientific Research and Development Ltda

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2022
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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