Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK investigational drug · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 100mg |
| Cohort 2 | EXPERIMENTAL | 200mg |
| Cohort 3 | EXPERIMENTAL | 400mg |
| Cohort 4 | EXPERIMENTAL | 800mg |
| Cohort 5 | EXPERIMENTAL | 1500mg |
| Cohort 6 | EXPERIMENTAL | 2000mg |
| Cohort 7 | EXPERIMENTAL | 800mg with food |
| Cohort 8 | EXPERIMENTAL | 3000mg |
| Cohort 9 | EXPERIMENTAL | 4000mg |
| Name | Type | Description |
|---|---|---|
| 100 mg GSK investigational drug | DRUG | - |
| 200 mg GSK investigational drug | DRUG | - |
| 400 mg GSK investigational drug | DRUG | - |
| 800 mg GSK investigational drug | DRUG | - |
| 2000 mg GSK investigational drug | DRUG | - |
| 1500 mg GSK investigational drug | DRUG | - |
| 800mg fed GSK investigational drug | DRUG | - |
| 3000mg GSK investigational drug | DRUG | - |
| 4000mg GSK investigational drug | DRUG | - |
Inclusion Criteria: * Healthy * male * non-childbearling potential females * Body weight greater than or equal to 50 kg (110 lbs) for men and greater than or equal to 45 kg (99 lbs) for women. Body mass index (BMI) between 18.5-29.9 kg/m2 inclusive. * Capable of giving written informed consent, whi...
The GSK investigational drug is an experimental small molecule developed by GSK plc for bacterial infections. It has completed a single Phase 1 first-time-in-human pharmacokinetic study in 41 healthy adult volunteers in Australia. It is not an approved medicine and remains in clinical development.
The GSK investigational drug is being studied for bacterial infections. Its only recorded clinical trial enrolled healthy volunteers rather than patients, which is typical for a first-time-in-human pharmacokinetic study. No approved use has been established for this asset.
GSK plc, which trades under the ticker GSK, is the developer of the GSK investigational drug. The company sponsored the Phase 1 first-time-in-human pharmacokinetic study of the compound in Australia.
The GSK investigational drug is in Phase 1. One Phase 1 trial has been completed, and no active trials are ongoing. It is an investigational agent and has not been approved by the FDA or any other regulator for bacterial infections.
The GSK investigational drug has been studied in one completed trial, NCT00828867, titled Single Dose Escalation First Time in Human PK Study. It was a randomized, double-blind, controlled Phase 1 study that enrolled 41 healthy volunteers aged 18 years and older in Australia.