Healthy Adult ParticipantsPhase 1NCT07081503
Phase 1 Study of ADX-626 in Healthy Participants
A Phase 1 study testing ADX-626 in people with Healthy Adult Participants, run by ADARx Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
This first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- ADX-626
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2025to 30 Jun 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 45 years at the time of informed consent
- Males or women of non-childbearing potential (WONCBP)
- Willing to comply with all study requirements while participating
- Suitable venous access for blood sampling.
- Body weight ≥ 50 kg and a body mass index (BMI) ≤25 kg/m2
- Normal laboratory results including liver enzymes, hemoglobin, platelet count, and coagulation parameters
- Willing to use acceptable contraception methods if applicable
Who cannot join
- Significant medical condition such as hypertension, diabetes, cardiovascular disease, or cancer
- History of bleeding or coagulation disorders, prior instances of major bleeding, or a family history of bleeding disorders.
- Current infection
- Participation in an interventional drug study within the last 90 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Richmond Pharmacology
London, SE1 1YR
Ulrike Lorch, MD, 44 20 7042 5800, volunteer@richmondpharmacology.com
Ulrike Lorch, MD
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants
This first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626).
Read the detailed description
A Phase 1, first-in-human study to assess the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-626 compared with placebo in healthy participants.
- Conditions
- Healthy Adult Participants
- Being tested
- ADX-626, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-626Drug
siRNA duplex oligonucleotide
PlaceboDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| ADX-626 | Experimental | Not described Receives: Drug: ADX-626 |
| 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-626 in Healthy Participants
Incidence, relationship and severity of adverse events and serious adverse events
Measured: Day 1 to Day 365
Secondary outcomes (5)
Pharmacokinetics (PK) of ADX-626 - Maximum Concentration
Cmax
Measured: Day 1 to Day 29
Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration
Tmax
Measured: Day 1 to Day 29
Pharmacokinetics (PK) of ADX-626 - Exposure
Area Under the Curve (AUC)
Measured: Day 1 to Day 29
Pharmacodynamics (PD) of ADX-626 - Factor XI
Change from baseline in Factor XI measurements
Measured: Day 1 to Day 365
Pharmacodynamics (PD) of ADX-626 - Blood Clotting Time
Change from baseline in Activated Partial Thromboplastin Time (aPTT)
Measured: Day 1 to Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start12 Aug 2025
- Primary completion22 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADARx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arezoo Mirad, MD, Study director, ADARx Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081503
- Sponsor's protocol ID
- ADX-626-101
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07081503
- Acronym / sponsor ID
- ADX-626-101
- Conditions
- Healthy Adult Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- ADARx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 22 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Jul 2025 (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 first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626).
Detailed description
A Phase 1, first-in-human study to assess the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-626 compared with placebo in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADX-626 | Experimental | Drug: ADX-626 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 to 45 years at the time of informed consent
- Males or women of non-childbearing potential (WONCBP)
- Willing to comply with all study requirements while participating
- Suitable venous access for blood sampling.
- Body weight ≥ 50 kg and a body mass index (BMI) ≤25 kg/m2
Key exclusion criteria (4 listed)
- Significant medical condition such as hypertension, diabetes, cardiovascular disease, or cancer
- History of bleeding or coagulation disorders, prior instances of major bleeding, or a family history of bleeding disorders.
- Current infection
- Participation in an interventional drug study within the last 90 days
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-626siRNA duplex oligonucleotide | Drug | ADX-626 |
| PlaceboSaline | Drug | Placebo |
Primary outcome
Safety of ADX-626 in Healthy Participants
Time frame: Day 1 to Day 365
Incidence, relationship and severity of adverse events and serious adverse events
5 secondary outcomes
Pharmacokinetics (PK) of ADX-626 - Maximum Concentration
Time frame: Day 1 to Day 29
Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration
Time frame: Day 1 to Day 29
Pharmacokinetics (PK) of ADX-626 - Exposure
Time frame: Day 1 to Day 29
Pharmacodynamics (PD) of ADX-626 - Factor XI
Time frame: Day 1 to Day 365
Pharmacodynamics (PD) of ADX-626 - Blood Clotting Time
Time frame: Day 1 to Day 365
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 10 Sep 2026.
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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.
Arezoo Mirad, MD study director
ADARx Pharmaceuticals
1 site 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-626 in people with Healthy Adult Participants, run by ADARx Pharmaceuticals, Inc. at 1 site in United Kingdom.
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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Contact Nali Castillo (877-232-7974, info@adarx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ADX-626 in Healthy Participants (time frame: Day 1 to Day 365). 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 10 Sep 2026.