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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06205628

Enrollment

Registered

2024-01-16

Start date

2024-03-21

Completion date

2026-12-31

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Hypertension,Essential

Keywords

Hypertension

Brief summary

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

Interventions

DRUGADX-850

siRNA duplex oligonucleotide

DRUGPlacebo

Saline

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Masking Description

Intervention model description

Model Description

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026