Phase 1 Study of 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).
| Condition(s) | Healthy Adult Participants |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | ADARx Pharmaceuticals, Inc. |
| Locations | London, United Kingdom |
| Start date | 2025-08-12 |
| NCT ID | NCT07081503 |
| Official listing | https://clinicaltrials.gov/study/NCT07081503 |