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TD-3504 · 1 trial · 1 indication
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 ...
TD-3504 is an investigational small molecule being studied for the treatment of active mild and active moderate ulcerative colitis. It has also been evaluated in healthy subjects as part of clinical development. The drug is in Phase 1 clinical development and is not yet approved.
TD-3504 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker TBPH. The company is conducting clinical research on this investigational small molecule for gastrointestinal conditions.
TD-3504 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities for any use.
TD-3504 has one completed Phase 1 clinical trial, identified as NCT03103412, titled "TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)." The trial enrolled 32 participants in the United States and included healthy volunteers as well as subjects with active mild or moderate ulcerative colitis.
TD-3504 is the investigational name used for this compound in clinical development. No alternative names have been reported for this drug in the available clinical trial information.