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

Phase 1

Recruiting

• Conditions: Hypertension,Essential; Hypertension
• Interventions: Drug: ADX-850; Drug: Placebo

• Registration Number: NCT06205628
• Lead Sponsor: ADARx Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

This is a Phase 1, two-part, multi-center study evaluating safety, tolerability, PK, and PD of ADX-850. The study consists of two parts:

* Part 1: a randomized, blinded, placebo-controlled, parallel group, single ascending dose (SAD) study in participants with hypertension

* Part 2: an open-label study in participants with hypertension.

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Study Start: 2024-03-21
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ADX-850	ADX-850	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety of ADX-850 in Participants with Hypertension	365 days	Incidence, relationship and severity of adverse events and serious adverse events

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of ADX-850 - Maximum Concentration	8 days	Cmax
Pharmacokinetics (PK) of ADX-850 - Time to Maximum Concentration	8 days	Tmax
Pharmacokinetics (PK) of ADX-850 - Exposure	8 days	Area under the Curve (AUC)
Pharmacodynamics (PD) of ADX-850 - Blood Pressure	365 days	Change from baseline in blood pressure

Trial Locations

Locations (3)

Clinitrials Pty Ltd; 🇦🇺 Perth, Australia

CMAX Clinical Research; 🇦🇺 Adelaide, South Australia, Australia

Linear Clinical Research; 🇦🇺 Nedlands, Western Australia, Australia