Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SB-681323 oral tablets, Prednisolone
SB-681323 · 9 trials · 7 indications
Mean hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, white blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Mean hematology parameters including hemoglobin, MCHC were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Hematology parameter mean corpuscle hemoglobin was reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Absolute values of mean corpuscle volume were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Absolute values of reticulocytes and red blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Absolute values of albumin and total protein were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Absolute values of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Absolute values of direct bilirubin, total bilirubin, creatinine and uric acid were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Absolute values of calcium, chloride, glucose, bicarbonate, potassium, sodium and Urea/BUN were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Absolute values of Estradiol were reported. If sample for clinical chemistry test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Absolute values of Blood pH at screening were reported as clinical chemistry parameter.
Absolute values of SBP and DBP were reported.
Absolute values of mean heart rate were reported.
Absolute values of mean percent O2 in blood were reported.
Assessment of SaO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.
Assessment of level of positive end expiratory pressure was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.
Assessment of mean level of peak and plateau ventilator pressures was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.
Assessment of mean FiO2 via pulse oximetry was planned for cohort 1 and 3 at Day 1 (4 h), Day 2 (pre-dose) and Day 3 (pre-dose and 24 h) and for cohort 2 and 4: Day 2 (pre-dose) and Day 3 (pre-dose and 24 h). However, the analyzable data was not collected for this parameter.
12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measures RR, PR, QRS, QT, and QTc intervals. Absolute mean values of PR, QRS, QT, and QTcB, QTcF, RR intervals were reported.
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Participants were asked to rate their overall pain intensity for the last 24 hours, daily before retiring to bed. This constituted the Daily Pain Score. The 11 point pain intensity numerical rating scale ranged from 0 to 10, where 0 represents "No pain" and 10 represents "Maximum pain imaginable". It was used for the subjective assessment of the pain. The score ranged from 0 to 10, where 0 represented absence of symptoms and higher score indicated more severe symptoms. The average daily pain over Week 1 (Day 7) was calculated as the mean of days 2 to 6 inclusive and for week 2 (Day 14), days 8 to 13 inclusive. Participants were instructed to record their daily pain score on a dairy card and calculations of average weekly pain scores were performed on the basis of diary cards review.
CRP levels were compared between SB-681323 and placebo 72 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.
Levels of ex-vivo LPS induced TNFα in whole blood at 1, 2, 6 and 24 hrs post-dose
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - SB-681323 Intravenous 3mg | EXPERIMENTAL | 3mg SB-681323 Intravenous administration, infused over 4 hours |
| Cohort 2 - SB-681323 Intravenous 7.5 mg | EXPERIMENTAL | 7.5 mg SB-681323 Intravenous administration infused over 24 hours |
| Cohort 3 - SB-681323 Intravenous 7.5mg | EXPERIMENTAL | 7.5 mg SB-681323 Intravenous administration infused over 4 hours |
| Cohort 4 - SB-681323 Intravenous 10mg | EXPERIMENTAL | 10 mg SB-681323 Intravenous administration infused over 24 hours |
| Combined Placebo | EXPERIMENTAL | Placebo to match intervention |
| SB681323 | EXPERIMENTAL | Patients with pain associated with peripheral nerve injury and/or compression will be recruited for this study. |
| Placebo | EXPERIMENTAL | Patients with pain associated with peripheral nerve injury and/or compression will be recruited for this study. |
| Randomised, double-blind, five-way crossover | EXPERIMENTAL | A randomised, double-blind, double-dummy, placebo-controlled, five-way crossover study to assess the effects of single oral doses of SB-681323 (7.5 mg and 25 mg) and prednisolone (10 mg and 30 mg) on biomarkers in induced sputum and blood in COPD patients. |
| Name | Type | Description |
|---|---|---|
| SB-681323 Intravenous 3mg | DRUG | 3 mg SB-681323 Intravenous administration infused over 4 hours |
| SB-681323 Intravenous 7.5 mg | DRUG | 7.5 mg SB-681323 Intravenous administration infused over 24 hours |
| SB-681323 Intravenous 7.5mg | DRUG | 7.5 mg SB-681323 Intravenous administration infused over 4 hours |
| SB-681323 Intravenous 10mg | DRUG | 10 mg SB-681323 Intravenous administration infused over 24 hours |
| Placebo | OTHER | Placebo to match intervention |
| SB681323 | DRUG | 15 milligrams (mg)/day |
| SB-681323 | DRUG | - |
| Prednisolone | DRUG | - |
| SB-681323 oral tablets | DRUG | - |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Male or female, 18 - 80 years of age (inclusive) with major trauma admitted to the Intensive Care Unit (ICU). * Injury Severity score (ISS) \>16 to \<70 (exclusive) * A female ...
SB-681323 is an investigational small molecule developed by GSK plc for immunology indications. It has been studied in Phase 2 clinical trials in acute lung injury, neuropathic pain, and rheumatoid arthritis, and in Phase 1 trials involving healthy volunteers and methotrexate interaction. It is not described as approved and remains a clinical-stage research compound.
SB-681323 has been studied in clinical trials for acute lung injury or ARDS, neuropathic pain, and rheumatoid arthritis. Trial conditions also include coronary heart disease, chronic obstructive pulmonary disease, and inflammation. These are investigational uses evaluated in research studies, not approved indications.
SB-681323 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trial program for the compound across Phase 1 and Phase 2 studies conducted in the United States, United Kingdom, Australia, Germany, and Russia.
SB-681323 is in Phase 2 development. Four clinical trials have been completed, including two Phase 2 studies and two Phase 1 studies, with no active trials ongoing. The compound is investigational and has not been described as approved for any indication.
SB-681323 has been evaluated in four completed trials: NCT00996840 in acute lung injury or ARDS, NCT00439881 in healthy adult subjects, NCT00419809 as a methotrexate interaction study in rheumatoid arthritis, and NCT00390845 in patients with neuropathic pain. Total enrollment across these studies was 189 participants.
Yes, SB681323 is an alternative spelling of SB-681323, the same investigational compound. Other names used for it include SB-681323 oral tablets and SB-681323 Intravenous 3mg, which refer to different formulations and routes of administration studied in its clinical program.