What is ADX-626 studying for healthy adults?

ADX-626 is being studied to understand its safety, how it moves through the body, and its biological effects in healthy adults. Researchers want to see how ADX-626 affects blood clotting and factor XI levels. ADARx Pharmaceuticals, Inc. is leading this research to learn more about this new drug.

Who may be eligible for this healthy adult clinical trial?

Adults aged 18 to 45 who are male or women not able to become pregnant may be eligible. Participants must have no significant medical conditions, normal lab results, and meet weight and BMI requirements. They should be willing to follow study rules. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy adult clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 1

Age: 18Years - 45Years

All Genders

Healthy Volunteers

ID07081503

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess ADX-626 Safety and Effects in Healthy Adults

Led by ADARx Pharmaceuticals, Inc. · Updated on 2026-03-02

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a Phase 1, first-in-human study to evaluate the safety, tolerability, and how the body processes ADX-626 compared with a placebo in healthy adults aged 18 to 45. The study focuses on understanding the pharmacokinetics and pharmacodynamics of ADX-626, a siRNA duplex oligonucleotide, which includes how the drug affects blood clotting and factor XI levels. Participants will be randomly assigned to receive either ADX-626 or a placebo saline in a double-blinded manner. The study will monitor safety and drug behavior from Day 1 up to Day 365. Key measurements include maximum drug concentration, timing, overall exposure, and blood clotting times over this period. During the study, participants will undergo blood sampling and laboratory testing to assess safety, liver function, blood counts, and coagulation. Researchers will collect data on drug levels and biological effects at scheduled times. Participants must comply with study requirements and contraception guidelines if applicable. The entire participation lasts for one year, including monitoring for safety and drug effects.

CONDITIONS

Brief Title

Phase 1 Study of ADX-626 in Healthy Participants

Who Can Participate

Age: 18Years - 45Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Age 18 to 45 years at the time of informed consent
Male or woman of non-childbearing potential
Willing to comply with all study requirements during participation
Suitable venous access for blood sampling
Body weight 50 kg or more and body mass index 25 kg/m2 or less
Normal lab results including liver enzymes, hemoglobin, platelet count, and coagulation parameters
Willing to use acceptable contraception methods if applicable

You will not qualify if you...

Significant medical conditions such as hypertension, diabetes, cardiovascular disease, or cancer
History of bleeding or coagulation disorders, major bleeding, or family history of bleeding disorders
Current infection
Participation in an interventional drug study within the last 90 days

Research Team

Nali Castillo

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