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NCT Number: NCT07081503

Phase 1 Study of ADX-626 in Healthy Participants

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).

Recruiting

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Key information

Conditions

Healthy Adult Participants

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Richmond Pharmacology

London, SE1 1YR, United Kingdom

Location status: Recruiting

Location contact

Ulrike Lorch, MD

CONTACT

[email protected]

44 20 7042 5800

Ulrike Lorch, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADX-626

Drug

siRNA duplex oligonucleotide

Placebo

Drug

Saline

Primary outcomes

  1. Safety of ADX-626 in Healthy Participants

    Time frame: Day 1 to Day 365

    Incidence, relationship and severity of adverse events and serious adverse events

Secondary outcomes

  1. Pharmacokinetics (PK) of ADX-626 - Maximum Concentration

    Time frame: Day 1 to Day 29

    Cmax

  2. Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration

    Time frame: Day 1 to Day 29

    Tmax

  3. Pharmacokinetics (PK) of ADX-626 - Exposure

    Time frame: Day 1 to Day 29

    Area Under the Curve (AUC)

  4. Pharmacodynamics (PD) of ADX-626 - Factor XI

    Time frame: Day 1 to Day 365

    Change from baseline in Factor XI measurements

  5. Pharmacodynamics (PD) of ADX-626 - Blood Clotting Time

    Time frame: Day 1 to Day 365

    Change from baseline in Activated Partial Thromboplastin Time (aPTT)

Study contacts

Contact information is provided by the study sponsor or research team.

Nali Castillo

CONTACT

[email protected]

877-232-7974

Sponsors and collaborators

Lead sponsor

ADARx Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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