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An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics, immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in healthy male subjects
Interleukin-13 (IL-13) and IL-4 are mediators in the pathogenesis of established asthmatic disease. GSK2434735 is a bispecific antibody to IL-13 and IL-4. The purpose of this open label, sequential cohort, exploratory First Time in Human (FTIH) study is to evaluate the pharmacokinetics (PK) profile of GSK2434735 after a single low intravenous or subcutaneous dose in healthy male volunteers, and to assess if the pharmacokinetics (PK) parameters can be scaled from monkey to man. In addition, the safety and tolerability will be monitored and the study will assess if antibodies are generated to GSK2434735.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 GSK2434735 | Experimental | Cohort 1: Single intravenous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose. |
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| Cohort 2 GSK2434735 | Experimental | Cohort 2: Single subcutaneous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous (IV) single dose | Drug | GSK2434735 administered as a single intervenous dose at the beginning of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Pharmacokinetics | Cmax, tmax, AUC, CL, t1/2 | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG) | Change from baseline for PR, RR, QRS, QT, QTc measurements at Day 42 | 42 days |
| Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| Results for study 114594 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114594 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Subcutaneous (SC) single dose | Drug | GSK2434735 administered as a single subcutaneous dose at the beginning of the study |
|
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Change from baseline for systolic and diastolic blood pressure and heart rate measurements at 42 Days |
| 42 days |
| Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events | Clinically relevant changes from baseline in subject's disposition at Day 42 | 42 days |
| Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis | Changes from baseline values of hematologic , chemistry and urinary testing parameters at Day 42 | 42 days |
| Assessment of human anti-drug antibodies (ADA) in blood | Incidence of human anti-drug antibodies (ADA) at Day 42 | 42 days |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114594 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114594 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114594 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114594 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114594 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114594 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |