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| ID | Type | Description | Link |
|---|---|---|---|
| C24027 | Other Identifier | Richmond Pharmacology |
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This is a first-in-human (FIH), single-center, randomised, double-blind, placebo-controlled, single ascending dose (SAD) study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CITY-FXI in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation.
The study will be conducted in two parts:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CITY-FXI in Healthy Adults (Part A) | Experimental |
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| In Healthy Adults (Part A) | Placebo Comparator |
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| CITY-FXI in Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B) | Experimental |
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| In Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CITY-FXI | Drug | siRNA (subcutaneous injection) |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) | To evaluate the safety and tolerability of a single dose of CITY-FXI in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation | Through study completion, up to Day 360 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation | Day -1 to Day 3 |
| Area under plasma concentration time curve (AUC) of CITY-FXI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| City Therapeutics | Contact | 857-219-5440 | clinicaltrials@citytx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology | Recruiting | London | SE1 1YR | United Kingdom |
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| Placebo | Drug | Saline (subcutaneous injection) |
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To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation |
| Day -1 to Day 3 |
| Amount excreted in urine (Ae) of CITY-FXI | To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation | Day -1 to Day 3 |
| Change from baseline in levels of plasma Factor XI (FXI) | To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation | Up to Day 360 |
| Change from baseline of Factor XI (FXI) activity | To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation | Up to Day 360 |
| Change from baseline in activated partial thromboplastin time (aPTT) | To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation | Up to Day 360 |