This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in participants with hypertension.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Safety of ADX-850 in Participants with Hypertension — 365 days Incidence, relationship and severity of adverse events and serious adverse events
Trial sites (3)
Facility
City
Region
Status
CMAX Clinical Research
Adelaide
South Australia
Linear Clinical Research
Nedlands
Western Australia
Clinitrials Pty Ltd
Perth
Australia
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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