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

ADARx Pharmaceuticals

Status and phase

Active, not recruiting

Phase 1

Conditions

Hypertension,Essential

Hypertension

Treatments

Drug: ADX-850

Drug: Placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06205628

ADX-850-101

Details and patient eligibility

About

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

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)