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Active (not recruiting) Phase 1 NCT06205628

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

Phase 1 – testing safety in a small group of people
Conditions: Hypertension Hypertension,Essential

Sponsor: ADARx Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in participants with hypertension.
Who can participate
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)
Interventions
ADX-850
DRUG
Placebo
DRUG
Locations 3
Australia (3)
CMAX Clinical Research
Adelaide , South Australia
Linear Clinical Research
Nedlands , Western Australia
Clinitrials Pty Ltd
Perth
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
21.03.2024
Completion date
31.12.2026
Registry ID
NCT06205628
Source
clinicaltrials.gov
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