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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01015014 | Safety, Pharmacokinetics (PK) and Tolerability Study of a Novel Drug for Treatment of Bacterial Infections | PHASE1 | COMPLETED | 64 | — | — | Nov 5, 2009 | May 13, 2010 | Mar 5, 2019 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| AN3365 | ACTIVE_COMPARATOR | - |
| Saline | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AN3365 | DRUG | LP, 600 mg vial; reconstituted in Normal Saline |
| Placebo | DRUG | 0.9% sodium chloride for injection |
Inclusion Criteria: * Young healthy males, 18-45 years (inclusive) of age * Healthy as judged by a responsible physician with no clinically significant abnormality * Surgically sterile OR agrees to abstain from sexual intercourse with a female partner OR agrees to use a condom and spermicide during...