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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02293161 | Single Ascending Doses Study of Anti- Interleukin-7 Receptor α Monoclonal Antibody (GSK2618960) in Healthy Volunteers | PHASE1 | COMPLETED | 18 | — | — | Nov 11, 2014 | Sep 1, 2015 | May 9, 2017 | 1 | United Kingdom |
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Vital signs includes systolic and diastolic blood pressure, pulse rate and body temperature.
Vital signs includes systolic and diastolic blood pressure, pulse rate and body temperature.
Single 12-lead ECGs will be obtained.
Single 12-lead ECGs will be obtained.
Haematology parameters includes Platelet Count, Red blood cells (RBC) Count, White blood cells Count (absolute) (WBC), Haemoglobin and Haematocrit
Haematology parameters includes Platelet Count, RBC, WBC, Haemoglobin and Haematocrit
Clinical chemistry includes Blood urea nitrogen, Potassium, Aspartate aminotransferase (SGOT), Total and direct bilirubin, Creatinine, Chloride, Alanine aminotransferase (SGPT), Albumin, Glucose, Total Carbon dioxide, Gamma glutamyltransferase, Total Protein, Sodium, Calcium and Alkaline phosphatase
Clinical chemistry includes Blood urea nitrogen, Potassium, SGOT, Total and direct bilirubin, Creatinine, Chloride, SGPT, Albumin, Glucose, Total Carbon dioxide, Gamma glutamyltransferase, Total Protein, Sodium, Calcium and Alkaline phosphatase
Urinalysis includes Specific gravity, pH, glucose, protein, blood and ketones by dipstick, Microscopic examination (if blood or protein is abnormal)
Urinalysis includes Specific gravity, pH, glucose, protein, blood and ketones by dipstick, Microscopic examination (if blood or protein is abnormal)
| Arm | Type | Description |
|---|---|---|
| Cohort A GSK2618960 | EXPERIMENTAL | Subjects will receive GSK2618960 0.6 milligram per kilogram (mg/kg) |
| Cohort A Placebo | PLACEBO_COMPARATOR | Subjects will receive Sodium Chloride Intravenous as placebo |
| Cohort B GSK2618960 | EXPERIMENTAL | Subjects will receive GSK2618960,planned dose being 2mg/kg. However, actual dose level for Cohort B may be adjusted based on the emerging data on safety, tolerability, PK and RO from Cohort A. The maximum dose will not exceed 2.4 mg/kg (i.e. a 4-fold dose escalation from 0.6 mg/kg) |
| Cohort B Placebo | PLACEBO_COMPARATOR | Subjects will receive Sodium Chloride Intravenous as placebo |
| Name | Type | Description |
|---|---|---|
| GSK2618960 | DRUG | GSK2618960 will be provided as 100 mg/mL solution for injection to be administered as single dose IV infusion that has to be diluted at the study site with placebo |
| Placebo | DRUG | It is Sodium Chloride Intravenous Infusion |
Inclusion Criteria: * Males aged between 18 and 65 years of age inclusive, at the time of signing the informed consent OR females of non-child bearing potential aged between 18 and 65 years of age at the time of signing the informed consent. Non-childbearing potential defined as:- pre-menopausal f...