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Recruiting
NCT07081503
Phase 1 Study of ADX-626 in Healthy Participants
Conditions: Healthy Adult Participants
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 44
Sponsor: ADARx Pharmaceuticals, Inc.
Location: Richmond Pharmacology London
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).
Eligibility 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
Source: ClinicalTrials.gov (NCT07081503). StuddyBuddy aggregates publicly available trial information.