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This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD6423 or placebo will be administered IV, and a 4- to 10-day follow-up period after discharge.
In Part 1 of the study (single ascending dose portion), approximately 40 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 5 dosage-level cohorts (AZD6423 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD6423 or placebo on Day 1. In Part 2 of the study (multiple ascending dose portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive three doses of either AZD6423 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: AZD6423 | Experimental | Subjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo. |
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| Placebo to match AZD6423 | Placebo Comparator | Subjects will participate in 1 of 8 groups and receive single or multiple doses of AZD6423 or matching placebo. In each group 6 subjects will receive AZD6423 and 2 subjects will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6423 | Drug | Drug: AZD6423 Single or Multiple doses via infusion. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety and tolerability of AZD6423 in healthy subjects via adverse events | The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers. | From Baseline up to 18 days |
| Assessment of the safety and tolerability of AZD6423 in healthy subjects via EEG | The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers. | From Baseline up to 6 days |
| Assessment of the safety and tolerability of AZD6423 in healthy subjects via ECG. | The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers. | From Baseline up to 18 days |
| Assessment of the safety and tolerability of AZD6423 in healthy subjects via vital signs (blood pressure and pulse). as well as body temperature and weight | The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers. | From Baseline up to 18 days |
| Assessment of the safety and tolerability of AZD6423 in healthy subjects via clinical laboratory tests (chemistry, hematology and urinalysis). | The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers. | From Baseline up to 18 days |
| Assessment of the safety and tolerability of AZD6423 in healthy subjects via psychiatric assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the PK profile for AZD6423 in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z), and area under the curve (AUC). | Secondary objectives are to assess the pharmacokinetics and pharmacodynamics of AZD6423 in healthy volunteers. | From Baseline up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Han, M.D. | California Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | United States |
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| Placebo |
| Drug |
Placebo to match AZD6423 Single or Multiple doses of matching placebo delivered via infusion |
|
The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers. |
| From Baseline up to 18 days |
| Assessment of the safety and tolerability of AZD6423 in healthy subjects via neurological exams. | The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers. | From Baseline up to 18 days |
| Assessment of the safety and tolerability of AZD6423 in healthy subjects via physical exams. | The primary objectives of this study are to assess the safety and tolerability of single and multiple ascending dosage levels of AZD6423 versus placebo in healthy volunteers. | From Baseline up to 18 days |
| Assessment of the pharmacodynamics of AZD6423 in terms of the relationship between plasma concentration of AZD6423 and EEG | Secondary objectives are to assess the pharmacokinetics and pharmacodynamics of AZD6423 in healthy volunteers. | From Baseline up to 7 days |