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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01710826 | A Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Genz-682452 in Healthy Volunteers | PHASE1 | COMPLETED | 36 | — | — | Oct 1, 2012 | Feb 1, 2013 | Mar 19, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Genz-682452 | EXPERIMENTAL | This study will include three cohorts for doses of Genz-682452: Dose 1, Dose 2, Dose 3. Each cohort will include 12 participants, 9 of whom will be administered Genz-682452 and 3 will be administered placebo. |
| Placebo | PLACEBO_COMPARATOR | Placebo comparator taken by participants randomized to the placebo arm in each of the three cohorts. Each cohort will include 12 participants, 9 of whom will be administered Genz-682452 and 3 will be administered placebo. |
| Name | Type | Description |
|---|---|---|
| Genz-682452 | BIOLOGICAL | Capsules for oral administration. |
| Placebo | BIOLOGICAL | Placebo capsules matching the Genz-682452 capsules. |
Inclusion Criteria: * Body weight between 50.0 and 95.0 kg, inclusive, if male and between 40.0 and 85.0 kg inclusive, if female, body mass index between 18.0 and 30.0 kg/m\^2, inclusive. * Certified as healthy by a comprehensive clinical assessment. Exclusion Criteria: * Any history or presence ...