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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06236009 | A First-In-Human Study of TAK-004 in Healthy Adults | PHASE1 | COMPLETED | 121 | — | — | Nov 1, 2024 | Oct 17, 2025 | Dec 15, 2025 | 1 | United States |
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...