Erectile Dysfunction Following Radical ProstatectomyPhase 1NCT05332340
Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered
A Phase 1 study testing BZ371A in people with Erectile Dysfunction Following Radical Prostatectomy and Erectile Dysfunction, run by Biozeus Biopharmaceutical S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer
- What is being tested?
- BZ371A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Nov 2022to 30 Nov 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women
- Body mass index > 19 and < 28.5 Kg/m2
- Is able to understand the Informed Consent Form (ICF)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Azidus Brasil Pesquisa Científica e Desenvolvimento
Valinhos, São Paulo
About this study
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
The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.
Read the 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.
- Conditions
- Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer, Radical Prostatectomy
- Being tested
- BZ371A
- Keywords
- Erectile Dysfunction, Radical Prostatectomy, Prostate Cancer
- Medical subject headings
- Erectile Dysfunction, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BZ371ADrug
Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Patients | Experimental | Healthy patients receiving topical application of BZ371A Receives: Drug: BZ371A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak Plasma Concentration
Measured: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
T1/2
Terminal half-life of BZ371A
Measured: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
AUC
Area under the curve (AUC) of plasma/serum/blood drug concentration-time curve
Measured: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Clearance (CL)
Clearance of BZ371A
Measured: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Vd
Distribution Volume of BZ371A
Measured: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Adverse Effects Evaluation
Number of Adverse Effects after compound application
Measured: All adverse effect will be collected from the beginning of the study up to one week after drug administration
Physical Exam
Number of participants with abnormal physical exam findings
Measured: Baseline and 1 week
Change in SBP
Number of participants with a significant change in Systolic Blood Pressure
Measured: Baseline and 1 week
Change in DBP
Number of participants with a significant change in Diastolic Blood Pressure
Measured: Baseline and 1 week
Change in Heart Rate
Change in Heart Rate (HR).
The data from this measure reflect changes calculated from the baseline.
Measured: Baseline and 1 week
Change in Respiratory Rate
Change in Respiratory Rate (RR).
The data from this measure reflect changes calculated from the baseline.
Measured: Baseline and 1 week
Change in Temperature
Temperature measurements.
The data from this measure reflect changes calculated from the baseline.
Measured: Baseline and 1 week
Basal Chest Electrocardiogram (ECG)
Number of participants with abnormal ECG readings
Measured: Baseline and 1 week
Blood Evaluation
Number of participants with abnormal laboratory test results
Measured: Baseline and 1 day
Urine Evaluation
Number of participants with abnormal urinalysis
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start16 Nov 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biozeus Biopharmaceutical S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Azidus Brasil Scientific Research and Development Ltda
- Responsible party
- Sponsor
- Investigators
- Regina M Doi, Principal investigator, Azidus Brasil Pesquisa Científica e LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332340
- Sponsor's protocol ID
- BZ371CLI003
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2022
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05332340
- Acronym / sponsor ID
- BZ371CLI003
- Conditions
- Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer, Radical Prostatectomy
- Keywords
- Erectile Dysfunction, Radical Prostatectomy, Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Biozeus Biopharmaceutical S.A.Industry (pharma, biotech, devices)
- Collaborators
- Azidus Brasil Scientific Research and Development Ltda
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Patients | Experimental | Drug: BZ371AHealthy patients receiving topical application of BZ371A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women
- Body mass index > 19 and < 28.5 Kg/m2
- Is able to understand the Informed Consent Form (ICF)
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BZ371ASingle dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A. | Drug | Healthy Patients |
Primary outcome
Cmax
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Peak Plasma Concentration
T1/2
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Terminal half-life of BZ371A
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
Clearance (CL)
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Clearance of BZ371A
Vd
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Distribution Volume of BZ371A
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
Physical Exam
Time frame: Baseline and 1 week
Number of participants with abnormal physical exam findings
Change in SBP
Time frame: Baseline and 1 week
Number of participants with a significant change in Systolic Blood Pressure
Change in DBP
Time frame: Baseline and 1 week
Number of participants with a significant change in Diastolic Blood Pressure
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.
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.
Change in Temperature
Time frame: Baseline and 1 week
Temperature measurements. The data from this measure reflect changes calculated from the baseline.
Basal Chest Electrocardiogram (ECG)
Time frame: Baseline and 1 week
Number of participants with abnormal ECG readings
Blood Evaluation
Time frame: Baseline and 1 day
Number of participants with abnormal laboratory test results
Urine Evaluation
Time frame: Baseline and 1 week
Number of participants with abnormal urinalysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Erectile Dysfunction Following Radical Prostatectomy
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Not yet recruiting
Shockwave Therapy on Treating Erectile Dysfunction Following Nerve-sparing Radical Prostatectomy.
Erectile Dysfunction
Recruiting
Tractography-Guided Nerve-Sparing in Prostate Cancer
Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy
Active, not recruiting
Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
Erectile Dysfunction Following Radical Prostatectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina M Doi principal investigator
Azidus Brasil Pesquisa Científica e LTDA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BZ371A in people with Erectile Dysfunction Following Radical Prostatectomy and Erectile Dysfunction, run by Biozeus Biopharmaceutical S.A. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.