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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03494712 | Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers | PHASE1 | COMPLETED | 49 | — | — | Feb 21, 2018 | Apr 10, 2019 | Feb 17, 2020 | 1 | Belgium |
Safety criterion
| Arm | Type | Description |
|---|---|---|
| S 95010 | EXPERIMENTAL | Increasing single doses of S 95010 to 5 subjects. |
| Placebo | PLACEBO_COMPARATOR | Increasing single doses of Placebo to 2 subjects. |
| Name | Type | Description |
|---|---|---|
| S 95010 | DRUG | Single administration of S 95010 in healthy volunteers |
| Placebo | OTHER | Single administration of placebo in healthy volunteers |
Inclusion Criteria: * Young healthy male subjects aged between 18 and 45 years (both inclusive) Exclusion Criteria: * Any acute or chronic illness or clinically relevant findings such as livers,kidney, spleen, cardiovascular disease, eye disease in the selection/ inclusion visit examinations * An...