Phase 1 Study of ADX-626 in Healthy Participants

Not Applicable

Not yet recruiting

• Conditions: Healthy Adult Participants
• Interventions: Drug: ADX-626; Drug: Placebo

• Registration Number: NCT07081503
• Lead Sponsor: ADARx Pharmaceuticals, Inc.

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study Start: 2025-07-14
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Primary Completion: 2027-01-22
• Study Completion: 2027-01-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX-626	ADX-626	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Richmond Pharmacology; 🇬🇧 London, United Kingdom