Status:
ACTIVE_NOT_RECRUITING
Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
Lead Sponsor:
ADARx Pharmaceuticals, Inc.
Collaborating Sponsors:
ADARx Australia Pty Ltd
Avance Clinical Pty Ltd.
Conditions:
Hypertension
Hypertension,Essential
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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)
Key Trial Info
Start Date :
March 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06205628
Start Date
March 21 2024
End Date
September 30 2026
Last Update
December 9 2025
Active Locations (3)
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1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
2
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
3
Clinitrials Pty Ltd
Perth, Australia