Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ADX-850 in Participants With Hypertension

This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in participants with hypertension.

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)