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TAK-004 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study investigational product (IP), whether or not the occurrence is considered related to the study IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study IP. An untoward finding generally may necessitate therapeutic intervention, require an invasive diagnostic procedure, or require discontinuation or a change in dose of IP or a concomitant medication. Any clinically significant vital signs, electrocardiogram (ECG)/telemetry/Holter monitoring, laboratory values will be considered as AEs.
| Arm | Type | Description |
|---|---|---|
| Part 1: TAK-004 or Placebo (Single Ascending Dose Cohorts) | EXPERIMENTAL | Participants will receive TAK-004 or matching-placebo subcutaneous injection on Day 1 in Cohort S1 using a sentinel dosing scheme in a double-blind manner. After dosing the first two participants in Cohort S1, the investigator will review all available safety and tolerability data up to 24 hours post-dose before dosing the remaining participants in the Cohort S2-S10. Single ascending doses are nominal and may be modified based on emerging safety and available PK data during the study but will have a corresponding dose that does not exceed the maximal defined exposure. |
| Part 2: TAK-004 or Placebo (Multiple Ascending Dose Cohorts) | EXPERIMENTAL | Participants will receive TAK-004 (dose to be decided \[TBD\]) or matching-placebo subcutaneous injection, once daily for 5 days (i.e., Day 1 to 5) in each 5 multi-ascending dose cohorts (M1-M5). The dose in Part 2 will be determined at the dose escalation meeting based upon emerging safety, tolerability, and available PK data from Part 1. |
| Part 3: TAK-004 or Placebo (Expansion Cohorts) | EXPERIMENTAL | Participants will receive TAK-004 (TBD) or matching-placebo subcutaneous injection on Day 1 in each single ascending dose expansion cohorts (E1 and E2). Doses will be determined at the dose escalation meeting based on safety, tolerability and available PK data from Parts 1 and 2. Expansion cohort 2 (optional) may be conducted at the sponsor's discretion after reviewing expansion cohort 1 data. |
| Name | Type | Description |
|---|---|---|
| TAK-004 | DRUG | TAK-004 subcutaneous injections. |
| Placebo | DRUG | Matching- placebo subcutaneous injections. |
Inclusion Criteria: To be eligible for participation in this study, the participant must: 1. Understand the study procedures and agree to participate by providing written informed consent. 2. Be willing and able to comply with all study procedures and restrictions and follow all rules and regulati...
TAK-004 is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited. It has been studied in a first-in-human Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition TAK-004 is intended to treat has not been disclosed.
TAK-004 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating TAK-004.
TAK-004 is in Phase 1 development. A first-in-human Phase 1 study in healthy adults has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA.
TAK-004 has been evaluated in one clinical trial, NCT06236009, titled A First-In-Human Study of TAK-004 in Healthy Adults. The Phase 1 trial enrolled 121 participants in the United States, was randomized, double-blind, and controlled, and is now completed.
The therapeutic use of TAK-004 has not been disclosed. The completed Phase 1 trial, NCT06236009, was conducted in healthy adult volunteers rather than in patients with a specific disease, so no indication has been publicly identified for this investigational small molecule.