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Phase 1 Study of ADX-626 in Healthy Participants

RecruitingPhase 1

Sponsor: ADARx Pharmaceuticals, Inc.

Conditions: Healthy Adult Participants

Interventions: ADX-626, Placebo

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

London, United Kingdom