RecruitingPhase 1NCT07081503

Phase 1 Study of ADX-626 in Healthy Participants

A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants

Sponsor

ADARx Pharmaceuticals, Inc.

Enrollment

44 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

healthy adult participants

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

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria7

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

Exclusion Criteria4

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

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