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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04964258 | A Study of TAK-105 in Healthy Adults | PHASE1 | COMPLETED | 80 | — | — | Jul 26, 2021 | Jun 20, 2023 | Aug 2, 2024 | 3 | United States |
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after the first dose of the study treatment and last dose of study treatment.
| Arm | Type | Description |
|---|---|---|
| Part 1: Placebo | PLACEBO_COMPARATOR | TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 1 | EXPERIMENTAL | TAK-105-a Dose 1, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 2 | EXPERIMENTAL | TAK-105-a Dose 2, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 3 | EXPERIMENTAL | TAK-105-a Dose 3, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 4 | EXPERIMENTAL | TAK-105-a Dose 4, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 5 | EXPERIMENTAL | TAK-105-a Dose 5, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 6 | EXPERIMENTAL | TAK-105-a Dose 6, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 7 | EXPERIMENTAL | TAK-105-a Dose 7, injection, subcutaneously, once on Day 1. |
| Part 2: Placebo | PLACEBO_COMPARATOR | TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks. |
| Part 2: TAK-105 Dose 1A | EXPERIMENTAL | TAK-105-a Dose 1A, injection, subcutaneously, once weekly for up to 4 weeks. |
| Part 2: TAK-105 Dose 2A | EXPERIMENTAL | TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week. |
| Name | Type | Description |
|---|---|---|
| TAK-105-a | DRUG | TAK-105-a subcutaneous solution. |
| TAK-105-a Placebo | DRUG | TAK-105-a placebo-matching solution. |
Inclusion Criteria: For All Cohorts 1. Must have a body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/m\^2). 2. Continuous nonsmoker who has not used nicotine and tobacco-containing products for at least 3 months prior to sc...