Phase 1 testing of ADX-626 in healthy adults
A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants
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 |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | ADARx Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT07081503 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
London
- Richmond Pharmacology — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Nali Castillo
- Email: npak-castillo@adarx.com
- Phone: 858-333-9022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.