Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in participants with hypertension.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
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)
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06205628
Intervention or treatment
DRUG: ADX-850
DRUG: Placebo
Conditions
- Hypertension
- Hypertension,Essential
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Research sites nearby
Closest Location:
CMAX Clinical Research
Select from list below to view details:
CMAX Clinical Research
Adelaide, South Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Clinitrials Pty Ltd
Perth, Australia
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Who is running the clinical trial?
ADARx Pharmaceuticals, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: ADX-850
| Drug: ADX-850 |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Safety of ADX-850 in Participants with Hypertension | Incidence, relationship and severity of adverse events and serious adverse events | 365 days |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of ADX-850 - Maximum Concentration | Cmax | 8 days |
| Pharmacokinetics (PK) of ADX-850 - Time to Maximum Concentration | Tmax | 8 days |
| Pharmacokinetics (PK) of ADX-850 - Exposure | Area under the Curve (AUC) | 8 days |
| Pharmacodynamics (PD) of ADX-850 - Blood Pressure | Change from baseline in blood pressure | 365 days |
References
Clinical Trials Gov: Safety, Tolerability, PK and PD of ADX-850 in Participants With HypertensionOther trials to consider
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