Prostate Cancer Clinical Trial
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
Verified date | January 2023 |
Source | Biozeus Biopharmaceutical S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Azidus Brasil Pesquisa Científica e Desenvolvimento | Valinhos | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Biozeus Biopharmaceutical S.A. | Azidus Brasil Scientific Research and Development Ltda |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax | Peak Plasma Concentration | 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose | |
Primary | T1/2 | Terminal half-life of BZ371A | 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose | |
Primary | 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 | |
Primary | Clearance (CL) | Clearance of BZ371A | 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose | |
Primary | Vd | Distribution Volume of BZ371A | 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose | |
Primary | Adverse Effects Evaluation | Adverse effect evaluation of compound use and application | All adverse effect will be collected from the beginning of the study up to one week after drug administration | |
Primary | Physical Exam | Number of participants with abnormal physical exam findings | Baseline and 1 week | |
Primary | Change in SBP | Change in Systolic Blood Pressure | Baseline and 1 week | |
Primary | Change in DBP | Change in Diastolic Blood Pressure | Baseline and 1 week | |
Primary | Change in Heart Rate (HR) | Change in Heart Rate | Baseline and 1 week | |
Primary | Change in Respiratory Rate (RR) | Respiratory Rate | Baseline and 1 week | |
Primary | Change in Temperature | Temperature measurements | Baseline and 1 week | |
Primary | Basal chest electrocardiogram (ECG) | Number of participants with abnormal ECG readings | Baseline and 1 week | |
Primary | Blood Evaluation | Number of participants with abnormal laboratory test results | Baseline and 1 day | |
Primary | Urine Evaluation | Number of participants with abnormal urinalysis | Baseline and 1 week |
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