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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00547014 | First Safety Study in Humans of a Single Dose of CPG 52364 | PHASE1 | COMPLETED | 61 | — | — | Sep 1, 2007 | Apr 1, 2008 | Mar 19, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 1mg | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Cohort 3 | EXPERIMENTAL | - |
| Cohort 4 | EXPERIMENTAL | - |
| Cohort 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo Comparator: Cohort 1 Placebo | DRUG | Drug: placebo for cohort 1 as single dose |
| 52364 3 mg | DRUG | 3 mg capsule single dose administered orally as a single dose |
| Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo | DRUG | Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose |
| 52364 10 mg | DRUG | Drug: 52364 30 mg capsule as a single dose |
| 52364 30 mg | DRUG | Drug: 52364 30 mg capsule administered as a single dose |
| 52364 100 mg | DRUG | Drug 52364 100 mg capsule administered as a single dose |
| 52364 1 mg | DRUG | 1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose |
Inclusion Criteria: * Normal body mass index and weight * No significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram Exclusion Criteria: * Current illness or history of medica...