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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00622609 | Anti-MAG First Administration to Human | PHASE1 | COMPLETED | 46 | — | — | Aug 1, 2007 | Apr 9, 2009 | Jul 21, 2017 | 2 | United States, Australia |
| Arm | Type | Description |
|---|---|---|
| Subjects receiving GSK249320A | EXPERIMENTAL | Eligible subjects will receive escalating doses of GSK249320A in cohort 1 to 6 with a starting dose of 0.04 milligrams/kilograms up to the maximum dose of 25 milligrams/kilograms, administered as a slow intravenous infusion over 1 hour on Day 1. |
| Subjects receiving placebo | PLACEBO_COMPARATOR | Eligible subjects will receive single dose of sodium chloride in cohort 1 to 6, administered as a slow intravenous infusion over 1 hour on Day 1. |
| Name | Type | Description |
|---|---|---|
| GSK249320A | DRUG | GSK249320A intravenous infusion will be formulated as 100 milligrams/milliliters in 2 milliliters vials (filled to 1 milliliter), in phosphate buffer and delivered by a syringe and programmable pump. |
| Placebo | DRUG | Sodium chloride intravenous infusion will be given as matching placebo. |
Inclusion Criteria: * Healthy adult men or women of non-child bearing potential (i.e. post-menopausal or surgically sterile e.g. hysterectomy or bilateral oophorectomy). If necessary, postmenopausal status will be confirmed by serum FSH and oestradiol concentrations at screening. Surgical sterility...