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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00838461 | Study Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016 | PHASE1 | COMPLETED | 32 | — | — | Mar 1, 2009 | Jun 1, 2009 | Aug 3, 2009 | 1 | United States |
| NCT00740649 | Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016 | PHASE1 | COMPLETED | 74 | — | — | Oct 1, 2008 | Mar 1, 2009 | Mar 31, 2009 | 1 | Japan |
| NCT00739232 | Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 | PHASE1 | COMPLETED | 74 | — | — | Sep 1, 2008 | Feb 1, 2009 | Aug 3, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | HSD-016 |
| 2 | PLACEBO_COMPARATOR | placebo |
| Active | ACTIVE_COMPARATOR | Active |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| HSD-016 | DRUG | - |
| placebo | DRUG | - |
Inclusion criteria: 1. Men or women of nonchildbearing potential aged 18 to 50 years. 2. Healthy as determined by investigator on the basis of medical history and physical examination, laboratory test results, and 12-lead ECG. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day. Exclusion c...