Phase 1 Study of ADX-626 in Healthy Participants

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07081503

Enrollment

Registered

2025-07-23

Start date

2025-08-12

Completion date

2027-06-30

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Participants

Brief 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).

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

DRUGADX-626

siRNA duplex oligonucleotide

DRUGPlacebo

Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Safety of ADX-626 in Healthy Participants	Day 1 to Day 365	Incidence, relationship and severity of adverse events and serious adverse events

Secondary

Measure	Time frame	Description
Pharmacokinetics (PK) of ADX-626 - Maximum Concentration	Day 1 to Day 29	Cmax
Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration	Day 1 to Day 29	Tmax
Pharmacokinetics (PK) of ADX-626 - Exposure	Day 1 to Day 29	Area Under the Curve (AUC)
Pharmacodynamics (PD) of ADX-626 - Factor XI	Day 1 to Day 365	Change from baseline in Factor XI measurements
Pharmacodynamics (PD) of ADX-626 - Blood Clotting Time	Day 1 to Day 365	Change from baseline in Activated Partial Thromboplastin Time (aPTT)

Countries

United Kingdom

Contacts

CONTACTNali Castillo

info@adarx.com877-232-7974

STUDY_DIRECTORArezoo Mirad, MD

ADARx Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026