Safety, Tolerability, PK and PD of ADX-850 in Participant... | NCT06205628

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

NCT06205628

Sponsor

ADARx Pharmaceuticals, Inc.

Status

Active, not recruiting

Last Update Posted

Jun 16, 2026Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Hypertension
Hypertension,Essential

Interventions

ADX-850
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2024Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 4, 2024

First Submission Date that Met QC Criteria

Jan 4, 2024

First Posted Date

Jan 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 16, 2026Actual

Name	Class
ADARx Australia Pty Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Label	Type	Description	Intervention Names
ADX-850	Experimental		Drug: ADX-850
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ADX-850	Drug	siRNA duplex oligonucleotide	ADX-850	siRNA

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK) of ADX-850 - Maximum Concentration	Cmax	8 days
Pharmacokinetics (PK) of ADX-850 - Time to Maximum Concentration	Tmax

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Aditya Patel, MD	ADARx Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
CMAX Clinical Research		Adelaide	South Australia	5000	Australia
Linear Clinical Research

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006973	Hypertension
D000075222	Essential Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D016372	RNA, Antisense
D016375	Antisense Elements (Genetics)
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012313	RNA