Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
2 ng GSK2445053 · 1 trial · 1 indication
General safety endpoints, including AEs, vital signs, 12-lead ECG, body temperature and clinical laboratory safety tests to evaluate the safety and nasal tolerability of single escalation doses of GSK2245035 in healthy volunteers and individuals with Allergic Rhinitis.
Nasal examination and nasal symptom to assess nasal tolerability of single escalating doses of GSK2245035 in subjects with Allergic Rhinitis
Evaluation of the induction of TLR7-induced blood biomarkers in the nasal lavage and nasal tissues of individuals with AR following single GSK2245035 administration versus placebo.
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1 GSK2445053 | EXPERIMENTAL | 2ng GSK2245053 |
| Part 1 Cohort 1 Placebo | PLACEBO_COMPARATOR | Placebo |
| Part 1 Cohort 2 GSK2445053 | EXPERIMENTAL | 20ng GSK2445053 |
| Part 1 Cohort 2 Placebo | PLACEBO_COMPARATOR | Placebo |
| Part 1 Cohort 3 GSK2245053 | EXPERIMENTAL | 100ng GSK2445053 |
| Part 1 Cohort 3 Placebo | PLACEBO_COMPARATOR | Placebo |
| Part 1 Cohort 4 GSK2445053 | EXPERIMENTAL | 200ng GSK2445053 |
| Part 1 Cohort 4 Placebo | PLACEBO_COMPARATOR | Placebo |
| Part 1 Cohort 5 GSK245053 | EXPERIMENTAL | 400ng GSK2445053 |
| Part 1 Cohort 5 Placebo | PLACEBO_COMPARATOR | Placebo |
| Part 1 Cohort 6 GSK2445053 | EXPERIMENTAL | 1000ng GSK2245053 |
| Part 1 Cohort 6 Placebo | PLACEBO_COMPARATOR | Placebo |
| Part 1 Cohort 7 GSK2445053 | EXPERIMENTAL | 2000ng GSK2445053 |
| Part 1 Cohort 7 Placebo | PLACEBO_COMPARATOR | Placebo |
| Part 1 Cohort 8 GSK2445053 | EXPERIMENTAL | 4000ng GSK2445053 |
| Part 1 Cohort 8 Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| 2 ng GSK2445053 | DRUG | 2ng GSK2445053 administered intranasally |
| 20ng GSK2445053 | DRUG | 20ng GSK2445053 administered intranasally |
| 100ng GSK2445053 | DRUG | 100ng GSK2445053 administered intranasally |
| 200ng GSK2445053 | DRUG | 200ng GSK2445053 administered intranasally |
| 400ng GSK2445053 | DRUG | 400ng GSK2445053 administered intranasally |
| 1000ng GSK2445053 | DRUG | 1000ng GSK2445053 administered intranasally |
| 2000ng GSK2445053 | DRUG | 2000ng GSK2445053 administered intranasally |
| 4000ng GSK2445053 | DRUG | 4000ng GSK2445053 administered intranasally |
| Placebo | DRUG | Placebo administered intranasally |
Inclusion Criteria for all subjects (parts 1 and 2) * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history,physical examination, laboratory testsand cardiac monitoring. A subject with a clinical abnormality or laboratoryparameters...
GSK2445053 is an investigational small molecule being developed for seasonal allergic rhinitis. It is in Phase 1 clinical development, meaning it is still being studied in early-stage trials and is not yet approved for any use.
GSK2445053 is being developed by GSK plc, a pharmaceutical company traded on the London Stock Exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for seasonal allergic rhinitis.
GSK2445053 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving 61 participants.
GSK2445053 has one completed Phase 1 trial, NCT01480271, which investigated the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug in healthy volunteers and allergic rhinitics. The trial was placebo-controlled, double-blind, and enrolled 61 male participants in the Netherlands.
GSK2445053 is not the same as GSK2245035. The completed clinical trial NCT01480271 investigated GSK2245035, a different compound, in healthy volunteers and allergic rhinitics. GSK2445053 is a separate drug candidate.