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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02657122 | SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects | PHASE1 | COMPLETED | 72 | — | — | Dec 1, 2015 | Apr 1, 2016 | Jan 19, 2021 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| TD-1473 for SAD | EXPERIMENTAL | 6 of out 8 subjects per cohort will be randomized to receive TD-1473 |
| Placebo for SAD | PLACEBO_COMPARATOR | 2 of out 8 subjects per cohort will be randomized to receive placebo |
| TD-1473 for MAD | EXPERIMENTAL | 6 of out 8 subjects per cohort will be randomized to receive TD-1473 |
| Placebo for MAD | PLACEBO_COMPARATOR | 2 of out 8 subjects per cohort will be randomized to receive placebo |
| Name | Type | Description |
|---|---|---|
| TD-1473 for SAD | DRUG | SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose. |
| Placebo for SAD | DRUG | SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose. |
| TD-1473 for MAD | DRUG | MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing. |
| Placebo for MAD | DRUG | MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing. |
Inclusion Criteria: * Healthy male or female 19 to 55 years old * Willing and able to give informed consent * Body Mass Index (BMI) 18 to 30 kg/m2 * Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control * A...