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GSK1827771 · 1 trial · 1 indication
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...
GSK1827771 is an investigational small molecule being developed for rheumatoid arthritis. It is being studied in the immunology therapeutic area. The drug is currently in Phase 1 clinical development and is not yet approved for any use.
GSK1827771 is being developed by GSK plc, a pharmaceutical company traded on the New York Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and tolerability.
GSK1827771 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety and pharmacokinetics.
GSK1827771 has one completed clinical trial, NCT00539760, a Phase 1 study in healthy volunteers in the United States. The trial enrolled 45 participants and was placebo-controlled, though it was not double-blinded. The study focused on rheumatoid arthritis.
GSK1827771 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The drug has completed one early-stage study in healthy volunteers, but it has not yet demonstrated efficacy or received regulatory approval for any indication.