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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03103412 | TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC) | PHASE1 | COMPLETED | 32 | — | — | May 4, 2017 | Nov 8, 2017 | Jan 14, 2021 | 1 | United States |
To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing the number, severity, and type of treatment related adverse events.
| Arm | Type | Description |
|---|---|---|
| TD-3504 Low-Dose | EXPERIMENTAL | 6 healthy subjects and 6 ulcerative colitis subjects will be randomized to receive low-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. |
| TD-3504 Mid-Dose | EXPERIMENTAL | 6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. |
| TD-3504 High-Dose | EXPERIMENTAL | 6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose. |
| Placebo | PLACEBO_COMPARATOR | 6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose. |
| Name | Type | Description |
|---|---|---|
| TD-3504 | DRUG | TD-3504 |
| 15N2-tofacitinib | DRUG | 15N2-tofacitinib |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Male or female between 18 to 55 years old * Male subjects must abstain from sexual intercourse or use a highly effective method of birth control * Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method ...