Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-105-a · 1 trial · 1 indication
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...
TAK-105-a is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in Phase 1 clinical development. The only completed trial evaluated its safety and tolerability in healthy adults in the United States.
TAK-105-a is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company conducted a Phase 1 study of the drug in healthy adults.
TAK-105-a is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.
TAK-105-a has one completed clinical trial, NCT04964258, titled 'A Study of TAK-105 in Healthy Adults.' This Phase 1, randomized, double-blind, placebo-controlled study enrolled 80 healthy volunteers in the United States.
TAK-105-a is also known as TAK-105. The clinical trial NCT04964258 refers to the drug as TAK-105, and the asset is listed under the name TAK-105-a in development records.