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This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose administration to healthy Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. AZD2423 | Experimental |
| |
| 2. Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2423 | Drug | oral solution, single dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables. | From screening period to follow-up visit, 40 days (Maximum). |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics of AZD2423 in plasma and urine. | Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately) | |
| Exploratory endpoints;Levels of CCL2 pre-and post dose | Blood sampling after dosing, 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Lorch, MD MFPM FRCA | Richmond Pharmacology Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Croydon | United Kingdom | ||||
| Research Site |
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| Drug |
oral solution,single dose |
|
| London |
| United Kingdom |