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GSK2618960 · 1 trial · 1 indication
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...
GSK2618960 is an investigational small molecule being developed for autoimmune diseases. It is a monoclonal antibody targeting the interleukin-7 receptor alpha. The drug is currently in Phase 1 clinical development, and it has been studied in healthy volunteers to assess its safety and tolerability.
GSK2618960 targets the interleukin-7 receptor alpha (IL-7Rα). By binding to this receptor, the drug is designed to modulate immune responses, which may be relevant for treating autoimmune diseases. This mechanism is being evaluated in early-stage clinical trials.
GSK2618960 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical research on this investigational drug for autoimmune diseases.
GSK2618960 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical evaluation.
GSK2618960 has one completed Phase 1 clinical trial, identified as NCT02293161. This study was a single ascending dose trial in healthy volunteers, conducted in the United Kingdom, with 18 participants. The trial was randomized, double-blind, and placebo-controlled.
Yes, GSK2618960 is an anti-interleukin-7 receptor alpha (IL-7Rα) monoclonal antibody. The clinical trial NCT02293161 describes it as an anti-IL-7Rα monoclonal antibody. It is being investigated for its potential role in treating autoimmune diseases.