Phase 1 Completed N=12 Supportive Care

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

Erectile Dysfunction Following Radical Prostatectomy · Erectile Dysfunction · Prostate Cancer · Radical Prostatectomy

Source: ClinicalTrials.gov NCT05332340 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcomePrimary: Cmax — NA ng/mL

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Cmax	NA	—
PRIMARY T1/2	NA	—
PRIMARY AUC	NA	—
PRIMARY Clearance (CL)	NA	—
PRIMARY Vd	NA	—
PRIMARY Adverse Effects Evaluation	2	—
PRIMARY Physical Exam	—	—
PRIMARY Change in SBP	1	—
PRIMARY Change in DBP	2	—
PRIMARY Change in Heart Rate	69.42	—
PRIMARY Change in Respiratory Rate	19	—
PRIMARY Change in Temperature	0.1	0.683
PRIMARY Basal Chest Electrocardiogram (ECG)	—	—
PRIMARY Blood Evaluation	—	—
PRIMARY Urine Evaluation	—	—

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.

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Data sourced from ClinicalTrials.gov (NCT05332340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.