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Recruiting NCT07081503

Phase 1 Study of ADX-626 in Healthy Participants

Phase I Interventional Healthy Adult Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADX-626, Placebo.
Who it may be relevant to
Registry conditions: Healthy Adult Participants. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed 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.

Interventions

  • Drug ADX-626
    siRNA duplex oligonucleotide
  • Drug Placebo
    Saline

Primary outcome measures

  • Safety of ADX-626 in Healthy Participants [Time frame: Day 1 to Day 365]
Secondary outcome measures (5)
  • Pharmacokinetics (PK) of ADX-626 - Maximum Concentration [Time frame: Day 1 to Day 29]
  • Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration [Time frame: Day 1 to Day 29]
  • Pharmacokinetics (PK) of ADX-626 - Exposure [Time frame: Day 1 to Day 29]
  • Pharmacodynamics (PD) of ADX-626 - Factor XI [Time frame: Day 1 to Day 365]
  • Pharmacodynamics (PD) of ADX-626 - Blood Clotting Time [Time frame: Day 1 to Day 365]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Richmond Pharmacology — London

Identifiers

NCT: NCT07081503 · ADX-626-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗