Phase 1 testing of ADX-626 in healthy adults
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants
Run by ADARx Pharmaceuticals, Inc. · NCT07081503 · Data updated 2026-11-12
This trial will test whether ADX-626 is safe and how the body processes it in healthy adults aged 18 to 45.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | ADARx Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | August 12, 2025 |
| Main results expected | January 22, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07081503 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults aged 18–45 with body weight ≥50 kg and BMI ≤25 kg/m2, normal lab tests, no significant medical conditions, and who are male or women of non-childbearing potential willing to follow study procedures.
✕Probably not a fit
People with chronic medical conditions (for example hypertension, diabetes, cardiovascular disease, cancer), abnormal labs, current infection, recent participation in other interventional drug studies, women of childbearing potential, or those outside the 18–45 age range are unlikely to qualify or benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first-in-human, phase 1, placebo-controlled trial of ADX-626 in healthy adult volunteers. Participants will be assigned to receive ADX-626 or placebo and undergo regular blood sampling and clinical checks to measure safety, pharmacokinetics (PK), and pharmacodynamics (PD). Key entry requirements include age 18–45, weight ≥50 kg with BMI ≤25 kg/m2, normal laboratory tests, and females must be of non-childbearing potential. Study visits will include dosing, serial blood draws for PK/PD analysis, and safety monitoring for adverse events.
Why it matters
Potential benefit: If successful, this work could enable further development of ADX-626 and eventually lead to a new therapeutic option after later-phase testing.
How similar studies have gone: Many first-in-human phase 1 PK/PD trials successfully define safety and drug handling in healthy volunteers, but ADX-626 itself has not yet been tested in humans.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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
Where it's running
-
Richmond Pharmacology
London, United Kingdom Recruiting
Study contacts
- Study coordinator: Nali Castillo
- Email: info@adarx.com
- Phone: 877-232-7974
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
How age affects germinal center responses after flu and rabies vaccines
Researchers will test how the immune system responds to flu and rabies vaccines in younger adults (18–40) and older adults (65+).
-
Magnetic field maps with NV sensors for non-invasive heart measurements
This study tests whether diamond-based NV magnetometers can non-invasively detect and map the heart's magnetic field in healthy adults.
-
Methylation analyses using home-based self-sampling in women with and without gynecological disease
This study tests whether self-collected urine and vaginal samples can reveal DNA methylation markers that distinguish people with gynecological (pre-)cancers from cancer-free controls.
-
Omega-3 status in healthy adults: comparing different fish-oil and algae-oil products
This study tests whether various fish-oil and algae-oil products can raise the Omega-3 Index in healthy adults who don’t eat much fatty fish.
-
A safe, carefully dosed test of TBD11 in healthy adults
This phase 1 study tests TBD11 in healthy adults to see if it is safe and tolerable and to understand how it behaves in the body, including how it interacts with other medicines.
-
Fosmanogepix in healthy adults: how it may interact with other drugs and heart rhythm
This study tests whether fosmanogepix (and its active form manogepix) changes how other medicines work in healthy adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.