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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02294851 | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects | PHASE1 | COMPLETED | 65 | — | — | Dec 31, 2014 | Apr 30, 2016 | Nov 6, 2017 | 2 | United States |
To evaluate the safety and tolerability of a single intravenous (IV) infusion of BMS-986168 in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Single Ascending dose cohorts | EXPERIMENTAL | Single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects. |
| Placebo | PLACEBO_COMPARATOR | BMS-986168 Placebo |
| Name | Type | Description |
|---|---|---|
| BMS-986168 | DRUG | - |
| BMS-986168 Placebo | DRUG | - |
Inclusion Criteria: * Healthy male and female subjects, who have no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations. * Body Mass Index (BMI) of 18.5-30 kg/m\^2, inclusive. BMI=weight (kg)/\[height(m)\]\^2. * Males an...