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TAK-781 · 1 trial · 2 indications
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the trial intervention.
Laboratory parameters will include hematology, chemistry and urinalysis. Any clinically significant change in laboratory values will be determined at the investigator's discretion.
The 12-lead ECG will be evaluated. Any clinically significant change in ECG assessment will be determined at the investigator's discretion.
Vital signs will include measurement of oral body temperature, supine blood pressure and heart rate. Any clinically significant change in vital signs will be determined at the investigator's discretion.
| Arm | Type | Description |
|---|---|---|
| Phase 1a (Part 1): TAK-781 SAD | EXPERIMENTAL | Healthy participants will receive a single dose of TAK-781 injection at different dose level cohorts (1-6) on Day 1 of the pre-defined treatment period. An additional cohort may be added to repeat a selected dose from one of the previously tested dose levels in order to assess safety and tolerability and/or to verify the level of target engagement (TE). |
| Phase 1a (Part 1): Placebo SAD | PLACEBO_COMPARATOR | Healthy participants will receive TAK-781 matching placebo injection on Day 1 of the pre-defined treatment period. |
| Phase 1a (Part 2): TAK-781 MAD | EXPERIMENTAL | Healthy participants will receive multiple doses of TAK-781 injection across five cohorts (1 to 5), with or without a loading dose during the pre-defined treatment period. An additional cohort may be added to repeat a selected dose level and/or dosing regimen from one of the previously tested dose levels and/or dosing regimens in order to assess safety and tolerability, and/or to verify the level of TE. |
| Phase 1a (Part 2): Placebo MAD | PLACEBO_COMPARATOR | Healthy participants will receive multiple doses of TAK-781 matching placebo injection, with or without a loading dose during the pre-defined treatment period. |
| Phase 1b (Part 3): TAK-781 | EXPERIMENTAL | Participants with non-cirrhotic PSC will receive a single dose of TAK-781 injection on Day 1 during the pre-defined treatment period. Part 3 will not begin until the SAD portion of the trial is considered complete. |
| Name | Type | Description |
|---|---|---|
| TAK-781 | DRUG | TAK-781 injection. |
| Placebo | DRUG | TAK-781 matching placebo injection. |
Inclusion Criteria: Phase 1a (SAD and MAD) 1. The participant is willing and able to fully comply with all trial procedures and requirements, in the investigator's opinion. 2. The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form...
TAK-781 is an investigational small molecule drug being developed by Takeda Pharmaceutical Company Limited for primary sclerosing cholangitis, a gastrointestinal condition. It is currently in Phase 1 clinical development and has not been approved by the FDA. The program includes one recruiting trial in the United States.
TAK-781 is being studied for primary sclerosing cholangitis, a chronic liver and bile duct condition. It is an investigational therapy in Phase 1 development, so it is not yet available as a treatment. The ongoing study enrolls adults with non-cirrhotic primary sclerosing cholangitis as well as healthy volunteers.
TAK-781 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the Phase 1 program evaluating the small molecule in primary sclerosing cholangitis. The drug remains investigational and has not received FDA approval.
TAK-781 is in Phase 1 clinical development. One trial is currently recruiting, and no trials have been completed. The study is randomized, double-blind, and placebo-controlled, and it is enrolling 134 participants in the United States. TAK-781 is investigational and has not been approved by the FDA.
TAK-781 is being evaluated in one Phase 1 trial, NCT07229911, titled A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC). The trial is recruiting, is placebo-controlled and double-blind, and plans to enroll 134 participants aged 18 years and older in the United States.