Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01480271 | An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2245035 in Healthy Volunteers and Allergic Rhinitics. | PHASE1 | COMPLETED | 61 | — | — | May 30, 2011 | Sep 30, 2011 | Jun 28, 2017 | 1 | Netherlands |
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...