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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 developed by Theravance Biopharma, Inc. for active mild to moderate ulcerative colitis. It has been studied in a Phase 1 clinical trial that enrolled healthy subjects and subjects with ulcerative colitis. It is not approved and remains in clinical development.
TD-3504 targets JAK1, JAK2, and JAK3, which are kinase enzymes. By inhibiting these Janus kinases, the drug is designed to interfere with inflammatory signaling pathways relevant to ulcerative colitis. The target class is kinase, and the molecule is a small molecule.
TD-3504 is developed by Theravance Biopharma, Inc., which trades under the ticker TBPH. The company is the sponsor of the clinical program studying the drug in ulcerative colitis.
TD-3504 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.
TD-3504 has been studied in one completed Phase 1 trial, NCT03103412, titled TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC). The trial was randomized, double-blind, and placebo-controlled, enrolling 32 participants in the United States.
TD-3504 is being developed for active mild ulcerative colitis and active moderate ulcerative colitis. It is an investigational therapy, so it is not currently available as a treatment. The completed Phase 1 trial included both healthy subjects and subjects with ulcerative colitis.