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Also known as GR121167 Solution
GR121167 · 1 trial · 1 indication
Cmax, AUC0-inf, AUC0-last, AUC0-12, C12 (Cτ), accumulation ratios (Ro, Rs)
vital signs, ECGs, clinical laboratory tests, and adverse events
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A | EXPERIMENTAL | In Arm A subjects will receive 100 mg of GR121167 in Period 1 and 300 mg of GR121167 in Period 2. In Period 3 subject will receive single doses of placebo on Day 1 and multiple doses of placebo from Day 3 to Day 8 |
| Treatment Arm B | EXPERIMENTAL | In Arm B subjects will receive 100 mg of GR121167 in Period 1 and placebo in Period 2. In Period 3 subject will receive 600 mg of GR121167 as single dose on Day 1 and multiple doses of GR121167 from Day 3 to Day8 |
| Treatment Arm C | EXPERIMENTAL | In Arm C subjects will receive placebo in Period 1, 300 mg of GR121167 in Period 2. In period 3 subject will receive 600 mg of GR121167 single dose on Day 1 and multiple doses from Day 3 to Day 8 |
| Name | Type | Description |
|---|---|---|
| GR121167 Solution | DRUG | GR121167 solution will be administered intravenously. For 100 mg subject will receive 10 milliliter (mL) of solution, 30 mL for 300 mg and 60 mL for 600 mg |
| Placebo | DRUG | Placebo solution will be administered intravenously. |
Inclusion Criteria: 1. Healthy as defined as being free from clinically significant illness or disease as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital sign, laboratory tests and ECG. 2. Japanese healthy m...
GR121167 is an investigational small molecule developed by GSK plc for the treatment of human influenza. It is a Phase 1 clinical candidate that has been studied in healthy adult volunteers. GR121167 is also referred to as GR121167 Solution.
GR121167 is being developed for the treatment of influenza in humans, an infectious disease indication. It has been evaluated in a Phase 1 study conducted in healthy Japanese male volunteers rather than in patients with confirmed influenza infection.
GR121167 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 clinical study of the compound in healthy Japanese male volunteers.
GR121167 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials of GR121167 are currently listed.
GR121167 has been studied in one completed Phase 1 trial, NCT01428479, titled a Phase 1 study of GR121167, single and multiple dose study in healthy Japanese males. The trial enrolled 18 participants in Japan and used a randomized, double-blind, controlled design.
Yes, GR121167 Solution is an alternative name for GR121167. Both names refer to the same investigational small molecule developed by GSK plc for human influenza.