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

NCT05332340 | Completed Phase 1 Results DMC

• 1 other identifier: BZ371CLI003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction; Prostate Cancer; Radical Prostatectomy

Keywords

Erectile Dysfunction; Radical Prostatectomy; Prostate Cancer

Outcome Measures

Primary Outcomes (15)

• Cmax

  Peak Plasma Concentration

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

• T1/2

  Terminal half-life of BZ371A

  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

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

• Clearance (CL)

  Clearance of BZ371A

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

• Vd

  Distribution Volume of BZ371A

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

• Adverse Effects Evaluation

  Number of Adverse Effects after compound application

  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

  Baseline and 1 week

• Change in SBP

  Number of participants with a significant change in Systolic Blood Pressure

  Baseline and 1 week

• Change in DBP

  Number of participants with a significant change in Diastolic Blood Pressure

  Baseline and 1 week

• Change in Heart Rate

  Change in Heart Rate (HR). The data from this measure reflect changes calculated from the baseline.

  Baseline and 1 week

• Change in Respiratory Rate

  Change in Respiratory Rate (RR). The data from this measure reflect changes calculated from the baseline.

  Baseline and 1 week

• Change in Temperature

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

  Baseline and 1 week

• Basal Chest Electrocardiogram (ECG)

  Number of participants with abnormal ECG readings

  Baseline and 1 week

• Blood Evaluation

  Number of participants with abnormal laboratory test results

  Baseline and 1 day

• Urine Evaluation

  Number of participants with abnormal urinalysis

  Baseline and 1 week

Study Arms (1)

Healthy Patients

EXPERIMENTAL

Healthy patients receiving topical application of BZ371A

Drug: BZ371A

Interventions

BZ371A DRUG

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

Healthy Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women
• Body mass index \> 19 and \< 28.5 Kg/m2
• Is able to understand the Informed Consent Form (ICF)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biozeus Biopharmaceutical S.A.: lead
• Azidus Brasil Scientific Research and Development Ltda: collaborator

Study Sites (1)

Azidus Brasil Pesquisa Científica e Desenvolvimento

Valinhos, São Paulo, Brazil

Location

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases

Limitations and Caveats

There were no relevant limitations and caveats to study execution

Results Point of Contact

• Title: Joaquim Herzog de Oliveira Knox
• Organization: Biozeus Biopharmaceutical S.A.

joaquim.knox@biozeus.com.br

+55 (21) 25239089

Study Officials

• Regina M Doi

  Azidus Brasil Pesquisa Científica e LTDA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: April 18, 2022
• Study Start: November 16, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)