Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Hypertension
Hypertension,Essential
Спонсор: ADARx Pharmaceuticals, Inc.
Налично на:
БГ
Обобщение
This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in participants with hypertension.
Кой може да участва
Key Inclusion Criteria:
* Body mass index (BMI) between 18 and 35 kg/m2
* Mild to moderate hypertension, mean of \>130 and \<165mmHg
* No use of antihypertensive medication for a minimum of 2 weeks
* Willing and able to comply with all study requirements
* Willing to take irbesartan as concomitant ARB therapy (Part 2 only)
* Must be a non-smoker for the duration of the study
Key Exclusion Criteria:
* Secondary hypertension
* Active malignancy and/or history of malignancy in the past 5 years
* History of liver disease, Gilbert's syndrome, nonalcoholic steatohepatitis, severe steatosis, or abnormal liver function test results
* Any active infection or acute illness
* Major surgery or significant traumatic injury occurring within 3 months
* Mean sitting diastolic BP (DBP) ≥110 mmHg
* Orthostatic hypotension
* Significant kidney disease or eGFR \<60 mL/min/1.73m2
* Abnormal potassium levels
* History or presence of clinically significant ECG abnormalities
* Treatment with another investigational product within 30 days prior to the first study drug administration
* Pregnant, intend to become pregnant during the course of the study, or lactating
* History of alcohol abuse
* Night shift workers (regular working hours between 10:00 PM and 6:00 AM)
* Any other significant medical history, such as major cardiovascular events or cancer
* Known history of intolerance to ARB medication (Part 2 only)