Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of influenza in humans. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being studied to assess its safety, tolerability, and pharmacokinetics in healthy volunteers.
GR121167 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's potential as a treatment for influenza.
GR121167 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.
GR121167 has one completed clinical trial registered under NCT01428479. This was a Phase 1, single and multiple dose study conducted in healthy Japanese males aged 20 years and older. The trial enrolled 18 participants and was completed in Japan.
GR121167 is the primary name for this investigational drug. No alternative names have been associated with it in the available clinical trial information. It is being studied specifically for its potential use in treating influenza.