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This study is divided into two parts:
Part A of the study is double blinded, randomized, placebo-controlled and aims to assess the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamic (PD) effect of a single intravenous (IV) infusion dose of GSK1070806 when administered to healthy participants of Japanese, Chinese and European/Caucasian ancestry.
Part B of the study is an open label single cohort arm to assess the safety, tolerability, PK and PD effect of a single IV bolus low dose of GSK1070806 in healthy participants of European/Caucasian ancestry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: GSK1070806 | Experimental | Participants in Part A will receive single dose of GSK1070806 intravenous (IV) infusion |
|
| Part B: GSK1070806 | Experimental | Participants in Part B will receive single dose of GSK1070806 IV bolus |
|
| Part A: Placebo | Placebo Comparator | Participants in Part A will receive single dose of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1070806 | Drug | Participants will receive GSK1070806 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Serum GSK1070806 area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-∞]) | Up to Week 24 | |
| Part A: Serum GSK1070806 area under the concentration-time curve from time zero to the last quantifiable time (AUC(0-t)) | Up to Week 24 | |
| Part A: Maximum observed serum concentration (Cmax) of GSK1070806 | Up to Week 24 | |
| Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Number of participants with AEs and SAEs | Up to Week 32 | |
| Part A: Total IL-18 concentrations in serum | Up to Week 24 | |
| Part B: Total IL-18 concentrations in serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cypress | California | 90630 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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In Part A the participants will be randomly assigned in each arm to receive either active or placebo interventions.
In Part B the participants will be assigned to receive only active intervention.
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In Part A the participants and investigators will be masked. In Part B there will be no masking.
| Placebo | Drug | Participants will receive placebo |
|
| Up to Week 32 |
| Part A: Number of participants with anti-drug antibody (ADA) formation | Up to Week 24 |
| Part B: Number of participants with ADA formation | Up to Week 32 |
| Las Vegas |
| Nevada |
| 89113 |
| United States |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000608195 | GSK1070806 |
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