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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-626 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADX-626 | Drug | siRNA duplex oligonucleotide |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of ADX-626 in Healthy Participants | Incidence, relationship and severity of adverse events and serious adverse events | Day 1 to Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of ADX-626 - Maximum Concentration | Cmax | Day 1 to Day 29 |
| Pharmacokinetics (PK) of ADX-626 - Time to Maximum Concentration | Tmax |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nali Castillo | Contact | 877-232-7974 | info@adarx.com |
| Name | Affiliation | Role |
|---|---|---|
| Aditya Patel, MD | ADARx Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology | Recruiting | London | SE1 1YR | United Kingdom |
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| Drug |
Saline |
|
| Day 1 to Day 29 |
| Pharmacokinetics (PK) of ADX-626 - Exposure | Area Under the Curve (AUC) | Day 1 to Day 29 |
| Pharmacodynamics (PD) of ADX-626 - Factor XI | Change from baseline in Factor XI measurements | Day 1 to Day 365 |
| Pharmacodynamics (PD) of ADX-626 - Blood Clotting Time | Change from baseline in Activated Partial Thromboplastin Time (aPTT) | Day 1 to Day 365 |