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| Name | Class |
|---|---|
| MedImmune Ltd | INDUSTRY |
| AstraZeneca | INDUSTRY |
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To assess the safety of the administration of the drug (CAT-354) in healthy Japanese subjects.
The study design allows a gradual escalation of dose with safety monitoring to ensure the safety of the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | CAT-354 will be administered by SC injection |
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| Cohort 2 | Experimental | CAT-354 will be administered by SC injection |
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| Cohort 3 | Experimental | CAT-354 will be administered by SC injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAT-354 | Drug | 150 mg CAT-354 or placebo given SC on Day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The safety and tolerability of a single dose SC injection of CAT-354 in healthy male and/or female Japanese subjects will be assessed through the incidence of adverse events (AEs), and the assessment of vital signs, physical examinations, laboratory parameters, and electrocardiograms. | Study Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | The PK variables and IM variables of CAT-354 in healthy Japanese subjects will be evaluated. The incidence rate of positive serum antibodies to CAT-354 will be reported by treatment group. | Study Day 71 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsuro Yagawa, M.D. | Astra Zeneca K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| C574065 | tralokinumab |
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| CAT-354 |
| Drug |
300 mg CAT-354 or placebo given SC on Day 1 |
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| CAT 354 | Drug | 600 mg CAT-354 or placebo given SC on Day 1 |
|