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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
12/06/2025
Titles & IDs
Public title
Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
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Scientific title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ADX-850 in Participants With Hypertension
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Secondary ID [1]
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ADX-850-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Hypertension,Essential
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Condition category
Condition code
Cardiovascular
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Hypertension
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ADX-850
Treatment: Drugs - Placebo
Treatment: Drugs - Angiotensin Receptor Blockers
Experimental: PART 1 - Active ADX-850 administered to participants with hypertension - Part 1 includes up to 7 sequential dose cohorts (4 planned and 3 optional) to evaluate doses ranging from 100 to 800 mg (Table 3). In each cohort, 8 participants will be randomized in a 3:1 ratio to ADX-850 or placebo with the option to increase enrollment to 16 participants at the Sponsor's discretion and with SRC agreement.
At the start of each cohort, 2 sentinel participants (1 ADX-850 and 1 placebo) will be treated. The Medical Monitor and Investigator will review the available safety data from the first 48 hours after dosing to ensure safety before continuing enrollment in that cohort.
Placebo comparator: PART 1 - Placebo administered to participants with hypertension - Part 1 includes up to 7 sequential dose cohorts (4 planned and 3 optional) to evaluate doses ranging from 100 to 800 mg (Table 3). In each cohort, 8 participants will be randomized in a 3:1 ratio to ADX-850 or placebo with the option to increase enrollment to 16 participants at the Sponsor's discretion and with SRC agreement.
At the start of each cohort, 2 sentinel participants (1 ADX-850 and 1 placebo) will be treated. The Medical Monitor and Investigator will review the available safety data from the first 48 hours after dosing to ensure safety before continuing enrollment in that cohort.
Experimental: PART 2 - Active ADX-850 administered to participants with hypertension - In Part 2, participants with hypertension will be dosed with ADX-850 in an open-label, parallel arm fashion. Participants whose SBP \>120 mmHg at Day 57 will be administered irbesartan, 150 to 300 mg, once daily. Dosing of the combination treatment group will begin with 2 sentinel participants who will be followed for safety for 48 hours after starting their irbesartan regimen before the decision is made by the Investigator and Medical Monitor to continue with combination treatment for all other participants who meet the criteria for irbesartan administration.
Experimental: PART 2 - Active ADX-850 plus ARB therapy administered to participants with hypertension - In Part 2, participants with hypertension will be dosed with ADX-850 in an open-label, parallel arm fashion. Participants whose SBP \>120 mmHg at Day 57 will be administered irbesartan, 150 to 300 mg, once daily. Dosing of the combination treatment group will begin with 2 sentinel participants who will be followed for safety for 48 hours after starting their irbesartan regimen before the decision is made by the Investigator and Medical Monitor to continue with combination treatment for all other participants who meet the criteria for irbesartan administration.
Treatment: Drugs: ADX-850
siRNA duplex oligonucleotide
Treatment: Drugs: Placebo
Saline
Treatment: Drugs: Angiotensin Receptor Blockers
Angiotensin receptor blocker
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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PART 1 - Safety in Participants with Hypertension
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Assessment method [1]
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To evaluate the safety and tolerability of ADX-850 in hypertension patients by incidence, and severity of adverse events and serious adverse events
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Timepoint [1]
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365 days
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Primary outcome [2]
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PART 2 - Safety in Participants with Hypertension
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Assessment method [2]
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To evaluate the safety and tolerability of ADX-850 in hypertension patients by incidence, nature, and severity of adverse events, adverse events of special interest, and serious adverse events
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Timepoint [2]
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365 days
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Secondary outcome [1]
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PART 1 - Pharmacokinetics in Participants with Hypertension
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Assessment method [1]
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To characterize the Pharmacokinetics of ADX-850 by measuring the Maximum Observed Concentration (Cmax) based on concentration in plasma
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Timepoint [1]
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8 days
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Secondary outcome [2]
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PART 1 - Biomarker activity in Participants with Hypertension
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Assessment method [2]
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Change from baseline in plasma concentration over time
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Timepoint [2]
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365 days
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Secondary outcome [3]
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PART 2 - Biomarker Activity in Participants with Hypertension on a stable dose of ARB
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Assessment method [3]
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To characterize the change from baseline in plasma concentration over time
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Timepoint [3]
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365 days
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Eligibility
Key inclusion criteria
* Body mass index (BMI) between 18 and 35 kg/m2
* Documentation of mild to moderate hypertension, mean of >130 and <165mmHg
* No use of antihypertensive medication for a minimum of 2 weeks or 5 half-lives
* Access to and ability to use antihypertensive medication/access to emergency services to treat hyper- or hypotensive events
* Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Willing and able to provide informed consent and comply with all study visits
* Willing to start or switch to irbesartan as concomitant ARB therapy, if applicable (Part 2 only)
* Negative urine drug and breath alcohol test
* Must be a non-smoker for the duration of the study
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Any significant medical history
* 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
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, red blood cell (RBC), hemoglobin, hematocrit, reticulocytes, gamma-glutamyl transferase (GGT), and creatinine must be within normal range at screening and prior to dosing
* Any active infection or acute illness
* Major surgery or significant traumatic injury occurring within 3 months
* Any other conditions that, in the opinion of the Investigator or Sponsor, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study
* Mean sitting diastolic BP (DBP) =110 mmHg at any time prior to randomization.
* Orthostatic hypotension
* eGFR <60 mL/min/1.73m2
* Abnormal potassium levels <3.5 and >5 mmol/L
* History or presence of clinically significant ECG abnormalities and corrected QTcF >450 ms prior to dosing
* Positive serology tests (HepB, Hep C, HIV)
* Use of unapproved prescription, vaccines, supplements/vitamins, or over-the counter medication
* Treatment with another investigational product concurrently or within 30 days prior to the first study drug administration
* Known hypersensitivity to any of the study drug ingredients
* Pregnancy, intent to become pregnant during the course of the study, or lactating women
* History or presence of alcohol abuse
* Blood donation within 30 days prior to study drug administration
* Night shift workers (regular working hours between 10:00 PM and 6:00 AM)
* Known history of intolerance to ARB medication (Part 2 only)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2026
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,WA
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Recruitment hospital [1]
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CMAX Clinical Research - Adelaide
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Recruitment hospital [2]
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Linear Clinical Research - Nedlands
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Recruitment hospital [3]
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Clinitrials Pty Ltd - Perth
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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- Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ADARx Pharmaceuticals, Inc.
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Address
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Other collaborator category [1]
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Other
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Name [1]
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ADARx Australia Pty Ltd
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/industry
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Name [2]
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Avance Clinical Pty Ltd.
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in patients with hypertension.
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Trial website
https://clinicaltrials.gov/study/NCT06205628
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Markus P Schlaich, MD
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Address
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Country
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Phone
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+61892240382
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Fax
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Email
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markus.schlaich@uwa.edu.au
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Contact person for scientific queries
Data sharing statement
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
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