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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06205628




Registration number
NCT06205628
Ethics application status
Date submitted
4/01/2024
Date registered
16/01/2024
Date last updated
20/07/2025

Titles & IDs
Public title
Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
Scientific title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ADX-850 in Participants With Hypertension
Secondary ID [1] 0 0
ADX-850-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Hypertension,Essential 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ADX-850
Treatment: Drugs - Placebo

Experimental: ADX-850 -

Placebo comparator: Placebo -


Treatment: Drugs: ADX-850
siRNA duplex oligonucleotide

Treatment: Drugs: Placebo
Saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of ADX-850 in Participants with Hypertension
Timepoint [1] 0 0
365 days
Secondary outcome [1] 0 0
Pharmacokinetics (PK) of ADX-850 - Maximum Concentration
Timepoint [1] 0 0
8 days
Secondary outcome [2] 0 0
Pharmacokinetics (PK) of ADX-850 - Time to Maximum Concentration
Timepoint [2] 0 0
8 days
Secondary outcome [3] 0 0
Pharmacokinetics (PK) of ADX-850 - Exposure
Timepoint [3] 0 0
8 days
Secondary outcome [4] 0 0
Pharmacodynamics (PD) of ADX-850 - Blood Pressure
Timepoint [4] 0 0
365 days

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment hospital [2] 0 0
Linear Clinical Research - Nedlands
Recruitment hospital [3] 0 0
Clinitrials Pty Ltd - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ADARx Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ADARx Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Avance Clinical Pty Ltd.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tim A Peters-Strickland, MD
Address 0 0
ADARx Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa A Melia, MD
Address 0 0
Country 0 0
Phone 0 0
858-333-9022
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06205628