Phase 1 Study of ADX-626 in Healthy Participants

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).

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.

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