Safety, Tolerability and PK Evaluation of BZ371A, Topically Administered

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biozeus Biopharmaceutical S.A.
• Collaborator: Azidus Brasil Scientific Research and Development Ltda

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, HPV, 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.