HypertensionPhase 1NCT06205628
Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension
A Phase 1 study testing ADX-850 in people with Hypertension and Hypertension,Essential, run by ADARx Pharmaceuticals, Inc. at 3 sites in Australia.
Trial summary
This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in participants with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Hypertension,Essential
- What is being tested?
- ADX-850
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesAustralia
- Study dates
- 21 Mar 2024to 31 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
CMAX Clinical Research
Adelaide, South Australia, 5000
Linear Clinical Research
Nedlands, Western Australia, 6009
Clinitrials Pty Ltd
Perth
About this study
Official title: 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.
- Conditions
- Hypertension, Hypertension,Essential
- Being tested
- ADX-850, Placebo
- Keywords
- Hypertension
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-850Drug
Also called siRNA
siRNA duplex oligonucleotide
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| ADX-850 | Experimental | Not described Receives: Drug: ADX-850 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ADX-850 in Participants with Hypertension
Incidence, relationship and severity of adverse events and serious adverse events
Measured: 365 days
Secondary outcomes (4)
Pharmacokinetics (PK) of ADX-850 - Maximum Concentration
Cmax
Measured: 8 days
Pharmacokinetics (PK) of ADX-850 - Time to Maximum Concentration
Tmax
Measured: 8 days
Pharmacokinetics (PK) of ADX-850 - Exposure
Area under the Curve (AUC)
Measured: 8 days
Pharmacodynamics (PD) of ADX-850 - Blood Pressure
Change from baseline in blood pressure
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start21 Mar 2024
- Primary completion6 Oct 2026
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Model Description
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADARx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ADARx Australia Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205628
- Sponsor's protocol ID
- ADX-850-101
- Status last verified
- Oct 2026
- First submitted
- 4 Jan 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ADX-850 in Participants With Hypertension
- ClinicalTrials.gov ID
- NCT06205628
- Acronym / sponsor ID
- ADX-850-101
- Conditions
- Hypertension, Hypertension,Essential
- Keywords
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- ADARx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ADARx Australia Pty Ltd
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 6 Oct 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in participants with hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| ADX-850 | Experimental | Drug: ADX-850 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX-850Also: siRNAsiRNA duplex oligonucleotide | Drug | ADX-850 |
| PlaceboSaline | Drug | Placebo |
Primary outcome
Safety of ADX-850 in Participants with Hypertension
Time frame: 365 days
Incidence, relationship and severity of adverse events and serious adverse events
4 secondary outcomes
Pharmacokinetics (PK) of ADX-850 - Maximum Concentration
Time frame: 8 days
Pharmacokinetics (PK) of ADX-850 - Time to Maximum Concentration
Time frame: 8 days
Pharmacokinetics (PK) of ADX-850 - Exposure
Time frame: 8 days
Pharmacodynamics (PD) of ADX-850 - Blood Pressure
Time frame: 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADX-850 in people with Hypertension and Hypertension,Essential, run by ADARx Pharmaceuticals, Inc. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ADX-850 in Participants with Hypertension (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.