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

NCT06205628 | Active Not Recruiting Phase 1

• 1 other identifier: ADX-850-101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hypertension; Hypertension,Essential

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

• Safety of ADX-850 in Participants with Hypertension

  Incidence, relationship and severity of adverse events and serious adverse events

  365 days

Secondary Outcomes (4)

• Pharmacokinetics (PK) of ADX-850 - Maximum Concentration

  8 days

• Pharmacokinetics (PK) of ADX-850 - Time to Maximum Concentration

  8 days

• Pharmacokinetics (PK) of ADX-850 - Exposure

  8 days

• Pharmacodynamics (PD) of ADX-850 - Blood Pressure

  365 days

Study Arms (2)

ADX-850

EXPERIMENTAL

Drug: ADX-850

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ADX-850 DRUG

siRNA duplex oligonucleotide

Also known as: siRNA

ADX-850

Placebo DRUG

Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ADARx Pharmaceuticals, Inc.: lead
• ADARx Australia Pty Ltd: collaborator

Study Sites (3)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

Clinitrials Pty Ltd

Perth, Australia

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

RNA, Small Interfering

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

RNA, Antisense; Antisense Elements (Genetics); Nucleic Acids, Nucleotides, and Nucleosides; RNA; Nucleic Acids; RNA, Small Untranslated; RNA, Untranslated

Study Officials

• Aditya Patel, MD

  ADARx Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: March 21, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

AU (3)