Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK1223249 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Subjects receiving GSK1223249 | EXPERIMENTAL | Eligible subjects will receive sequential dose of intravenous infusion of GSK1223249 with a starting dose of 0.01 milligram per kilogram followed by 0.1, 0.5, 1, 2.5, 5, 7.5, and 15 milligrams per kilograms. |
| Subjects receiving placebo | PLACEBO_COMPARATOR | Eligible subjects will receive intravenous infusion of placebo. |
| Name | Type | Description |
|---|---|---|
| PLACEBO | DRUG | Placebo |
| GSK1223249 | DRUG | I.V Infusion |
Inclusion Criteria: * Patients with diagnosis of familial or sporadic ALS, defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the revised World Federation of Neurology El Escorial criteria \[Rix Brooks 2000\]. * Onset o...
GSK1223249 is an investigational small molecule being developed for the treatment of Amyotrophic Lateral Sclerosis (ALS). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with ALS to evaluate its safety and tolerability.
GSK1223249 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Amyotrophic Lateral Sclerosis.
GSK1223249 is in Phase 1 clinical development. A first-in-human study of the drug in patients with Amyotrophic Lateral Sclerosis has been completed. The drug remains investigational and is not yet approved for any use.
GSK1223249 has one completed Phase 1 clinical trial, identified as NCT00875446, titled "First Time in Human Study of GSK1223249 in Amyotrophic Lateral Sclerosis." The trial enrolled 76 participants across the United States, France, Italy, and the United Kingdom.
Yes, the completed Phase 1 trial of GSK1223249 was randomized, double-blind, and placebo-controlled. The study enrolled 76 patients with Amyotrophic Lateral Sclerosis and was designed to assess the safety and tolerability of the drug compared to placebo.