Phase 1 Study of ADX-626 in Healthy Participants
A Phase 1, Randomized, Blinded, Placebo-Controlled Study to Assess ADX-626 in Healthy Participants
1 other identifier
interventional
44
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedStudy Start
First participant enrolled
August 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 22, 2027
March 2, 2026
January 1, 2026
1.4 years
July 3, 2025
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of ADX-626 in Healthy Participants
Incidence, relationship and severity of adverse events and serious adverse events
Day 1 to Day 365
Secondary Outcomes (5)
Pharmacokinetics (PK) of ADX-626 - Maximum Concentration
Day 1 to Day 29
Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration
Day 1 to Day 29
Pharmacokinetics (PK) of ADX-626 - Exposure
Day 1 to Day 29
Pharmacodynamics (PD) of ADX-626 - Factor XI
Day 1 to Day 365
Pharmacodynamics (PD) of ADX-626 - Blood Clotting Time
Day 1 to Day 365
Study Arms (2)
ADX-626
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Richmond Pharmacology
London, SE1 1YR, United Kingdom
Study Officials
- STUDY DIRECTOR
Aditya Patel, MD
ADARx Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2025
First Posted
July 23, 2025
Study Start
August 12, 2025
Primary Completion (Estimated)
January 22, 2027
Study Completion (Estimated)
January 22, 2027
Last Updated
March 2, 2026
Record last verified: 2026-01