NCT06205628Active, not recruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in participants with hypertension.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 4 Jan 2024
- Start date
- 21 Mar 2024
- Primary completion date
- 6 Oct 2026
- Lead sponsor
- ADARx Pharmaceuticals, Inc.
- Diseases
- High blood pressure
- NCT number
- NCT06205628
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 28
- From 21 Mar 2024 to the primary completion date, 6 Oct 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery or significant traumatic injury occurring within 3 months
- Treatment with another investigational product within 30 days prior to the first study drug administration
Other illness
- 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
- History of alcohol abuse
- Any other significant medical history, such as major cardiovascular events or cancer
- Known history of intolerance to ARB medication (Part 2 only)
Lab values
- Significant kidney disease or eGFR \<60 mL/min/1.73m2
- Abnormal potassium levels
Other
- Mean sitting diastolic BP (DBP) ≥110 mmHg
- Orthostatic hypotension
- History or presence of clinically significant ECG abnormalities
- Pregnant, intend to become pregnant during the course of the study, or lactating
- Night shift workers (regular working hours between 10:00 PM and 6:00 AM)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CMAX Clinical Research Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Linear Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Clinitrials Pty Ltd Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.