Overview
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).
Description
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.
Eligibility
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