Phase 1 Study of ADX-626 in Healthy Participants (ADX-626-101)

ADARx Pharmaceuticals

Status and phase

Not yet enrolling

Phase 1

Conditions

Healthy Adult Participants

Treatments

Drug: Placebo

Drug: ADX-626

Study type

Interventional

Funder types

Industry

Identifiers

NCT07081503

ADX-626-101

Details and patient eligibility

About

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).

Full 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.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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