Evaluating ADX-850 for treating hypertension

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

This study is testing a new medication called ADX-850 to see if it is safe and effective for people with high blood pressure.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: ADARx Pharmaceuticals, Inc. (Industry-sponsored)
• Locations: 2 sites (Adelaide, South Australia and 1 other locations)
• Trial ID: NCT06205628 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical study aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in individuals with hypertension. The study is divided into two parts: the first part involves a randomized, blinded, placebo-controlled design with single ascending doses across multiple cohorts, while the second part includes an open-label approach with a fixed dose of ADX-850 alongside an angiotensin receptor blocker (ARB) for participants with elevated blood pressure. Participants will be monitored closely for any adverse effects and changes in blood pressure.

Who should consider this trial

Good fit: Ideal candidates are adults with mild to moderate hypertension who meet specific BMI and health criteria.

Not a fit: Patients with secondary hypertension or significant medical histories may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with hypertension.

How similar studies have performed: Other studies have shown promise in evaluating new antihypertensive agents, but this specific approach with ADX-850 is novel.

Eligibility criteria

Inclusion Criteria:

* Body mass index (BMI) between 18 and 35 kg/m2
* Documentation of mild to moderate hypertension, mean of \>130 and \<165mmHg
* No use of antihypertensive medication for a minimum of 2 weeks or 5 half-lives
* Access to and ability to use antihypertensive medication/access to emergency services to treat hyper- or hypotensive events
* Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Willing and able to provide informed consent and comply with all study visits
* Willing to start or switch to irbesartan as concomitant ARB therapy, if applicable (Part 2 only)
* Negative urine drug and breath alcohol test
* Must be a non-smoker for the duration of the study

Exclusion Criteria:

* Any significant medical history
* 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
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, red blood cell (RBC), hemoglobin, hematocrit, reticulocytes, gamma-glutamyl transferase (GGT), and creatinine must be within normal range at screening and prior to dosing
* Any active infection or acute illness
* Major surgery or significant traumatic injury occurring within 3 months
* Any other conditions that, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study
* Mean sitting diastolic BP (DBP) ≥110 mmHg at any time prior to randomization.
* Orthostatic hypotension
* eGFR \<60 mL/min/1.73m2
* Abnormal potassium levels \<3.5 and \>5 mmol/L
* History or presence of clinically significant ECG abnormalities and corrected QTcF \>450 ms prior to dosing
* Positive serology tests (HepB, Hep C, HIV)
* Use of unapproved prescription, vaccines, supplements/vitamins, or over-the counter medication
* Treatment with another investigational product concurrently or within 30 days prior to the first study drug administration
* Known hypersensitivity to any of the study drug ingredients
* Pregnancy, intent to become pregnant during the course of the study, or lactating women
* History or presence of alcohol abuse
* Blood donation within 30 days prior to study drug administration
* Night shift workers (regular working hours between 10:00 PM and 6:00 AM)
* Known history of intolerance to ARB medication (Part 2 only)

Where this trial is running

Adelaide, South Australia and 1 other locations

• CMAX Clinical Research — Adelaide, South Australia, Australia (Recruiting)
• Linear Clinical Research — Nedlands, Western Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Markus P Schlaich, MD

Conditions Hypertension; Hypertension,Essential