Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB-681323 · 6 trials · 4 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.
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.
| 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 |
| 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 |
| 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 being studied for several conditions, including acute lung injury, rheumatoid arthritis, coronary heart disease, chronic obstructive pulmonary disease (COPD), and neuropathic pain. It is in Phase 2 clinical development for these indications.
SB-681323 is a small molecule being developed for inflammatory and pain conditions. Its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not described here.
SB-681323 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the drug's safety and efficacy.
SB-681323 is in Phase 2 clinical development. It has completed four clinical trials, including Phase 2 studies in COPD, coronary heart disease, and acute lung injury, as well as a Phase 1 study in COPD. It is not yet approved by regulatory authorities.
SB-681323 has completed four clinical trials: NCT00144859 in COPD patients, NCT00291902 in coronary heart disease patients undergoing percutaneous intervention, NCT00380133 in COPD patients, and NCT00996840 in patients at risk of acute lung injury or ARDS. All trials are completed.
Yes, SB-681323 is also referred to as SB681323 in some clinical trial records. Both names refer to the same investigational drug being developed by GSK plc for inflammatory and pain-related conditions.