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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01949103 | TD-1607 MAD Study in Healthy Subjects | PHASE1 | COMPLETED | 48 | — | — | Oct 1, 2013 | Jul 1, 2014 | Jan 19, 2021 | 1 | United States |
Adverse events
| Arm | Type | Description |
|---|---|---|
| TD-1607 or placebo (Dose1) | EXPERIMENTAL | TD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 2) | EXPERIMENTAL | TD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 3) | EXPERIMENTAL | TD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 4) | EXPERIMENTAL | TD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 5) [Optional] | EXPERIMENTAL | TD-1607 or placebo administered intravenously |
| TD-1607 or placebo (Dose 6) [Optional] | EXPERIMENTAL | TD-1607 or placebo administered intravenously |
| Name | Type | Description |
|---|---|---|
| TD-1607 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening. * Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg. Subject has no clinically significant abnormalities...