Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00539760 | A Phase I Rheumatoid Arthritis Study in Healthy Volunteers | PHASE1 | COMPLETED | 45 | — | — | Sep 5, 2007 | Apr 5, 2008 | Aug 15, 2017 | 2 | United States |
Blood samples will be collected at specific time points as a measure of safety
Blood samples will be collected at specific time points as a measure of safety
Urine samples will be collected at specific time points as a measure of safety
Systolic and diastolic blood pressure will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Heart rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Respiratory rate will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
Body temperature will be measured in a supine position after at least 5 minutes of rest as a measure of safety.
12-lead ECG measurements will be performed in a supine position after at least 5 minutes of rest as a measure of safety
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
| Arm | Type | Description |
|---|---|---|
| Subjects receiving GSK 1827771 in sub-cohort Xa (Cohort 1-5) | EXPERIMENTAL | Eligible subjects will receive GSK1827771 with the starting dose of 0.3 milligram (mg) |
| Subjects receiving placebo in sub-cohort Xa (Cohort 1-5) | PLACEBO_COMPARATOR | Eligible subjects will receive placebo matching to GSK1827771 |
| Subjects receiving GSK 1827771 in sub-cohort Xb (Cohort 1-5) | EXPERIMENTAL | Eligible subjects will receive GSK1827771 via injection |
| Subjects receiving placebo in sub-cohort Xb (Cohort 1-5) | PLACEBO_COMPARATOR | Eligible subjects will receive placebo matching to GSK1827771 |
| Subjects receiving GSK 1827771 in sub-cohort Xc (Cohort 1-5) | EXPERIMENTAL | Eligible subjects will receive GSK1827771 via injection |
| Subjects receiving placebo in sub-cohort Xc (Cohort 1-5) | PLACEBO_COMPARATOR | Eligible subjects will receive placebo matching to GSK1827771 |
| Name | Type | Description |
|---|---|---|
| GSK1827771 | DRUG | GSK1827771 will be administered using injection via subcutaneous (SC) route. |
| Placebo | DRUG | Placebo to GSK1827771 for Injection will be administered via SC route |
Inclusion Criteria: * Healthy adult men or women as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests and cardiac assessment. * Female subjects of non-childbearing potential. * Male subjects must agree to abstain from or a...