Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered
Lead Sponsor:
Biozeus Biopharmaceutical S.A.
Collaborating Sponsors:
Azidus Brasil Scientific Research and Development Ltda
Conditions:
Erectile Dysfunction Following Radical Prostatectomy
Erectile Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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) proced...
Eligibility Criteria
Inclusion
- Men or women
- Body mass index \> 19 and \< 28.5 Kg/m2
- Is able to understand the Informed Consent Form (ICF)
Exclusion
- 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.
Key Trial Info
Start Date :
November 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05332340
Start Date
November 16 2022
End Date
November 30 2022
Last Update
March 7 2025
Active Locations (1)
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1
Azidus Brasil Pesquisa Científica e Desenvolvimento
Valinhos, São Paulo, Brazil