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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Hypertension,Essential
• Intervention / Treatment: Drug: Placebo; Drug: ADX-850

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Perth, Australia
    • Clinitrials Pty Ltd
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • CMAX Clinical Research
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Saline
Experimental: ADX-850	Drug: ADX-850; siRNA duplex oligonucleotide; Other Names: siRNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PART 1 - Pharmodynamics in Participants with Hypertension	Change in blood pressure over time	365 days
PART 1 - Rescue Medication use in Participants with Hypertension	The incidence of rescue medication use	365 days
Part 1 - Immunogenicity in Participants with Hypertension	Evaluate the presence of anti-drug antibodies and anti-polyethylene glycol antibodies.	365 days
Part 2 - Pharmodynamics in Participants with Hypertension	Change is blood pressure over time	365 days
PART 2 - Biomarker activity in Participants with Hypertension	Evaluate biomarker activity over time	365 days
PART 2 - Rescue Medication in Participants with Hypertension	Evaluate the incidence of rescue medication use over time	365 days
Part 2 - Immunogenicity in Participants with Hypertension	Evaluate the presence of anti-drug and anti-PEG antibodies	365 days

Collaborators and Investigators

• Sponsor: ADARx Pharmaceuticals, Inc.
• Collaborators: ADARx Australia Pty Ltd
• Investigators: Study Director: Aditya Patel, MD, ADARx Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; RNA, Antisense; Antisense Elements (Genetics); RNA; RNA, Small Untranslated; RNA, Untranslated; RNA, Small Interfering
• Other Study ID Numbers: ADX-850-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No