A Study of TAK-755 in Adults With Acute Ischemic Stroke

Conditions

• Acute Ischemic Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TAK-755 — BIOLOGICAL
  TAK-755 IV infusion.
• Placebo — OTHER
  TAK-755 matching placebo IV infusion.

Study Details

Acute ischemic stroke (AIS) is a medical emergency that happens because of a sudden stop of blood flow to a part of the brain. This happens when a blood clot forms within the vessel (known as thrombotic occlusion) or a clot originating from somewhere else blocks a blood vessel (known as embolic occlusion). Strokes can cause serious health problems, death, and affect one's quality of life. To reduce long-term damage, it is important to restore blood flow to the brain as soon as possible. The main aim of this study is to check how safe TAK-755 is, and how well adults with AIS tolerate it. Other aims are to check how well TAK-755 helps participants to manage their everyday activities and to understand whether it helps reduce the seriousness of their stroke symptoms when compared to placebo. A placebo looks like TAK-755, but does not have any medicine in it, to make sure participants do not know which treatment they are taking. The participants will receive TAK-755 or placebo once; afterwards, their health will be monitored for about 3 months (90 days). All participants, regardless of their assignment to either TAK-755 or placebo, will receive the usual treatment for AIS as per the hospital's normal practice.

Key Dates

First listed

Feb 6, 2026

Start date

May 17, 2026

Status verified

Aug 2026

Primary completion

Dec 6, 2027

Completion

Dec 6, 2027

Study Design

Enrollment

222 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: TAK-755
  Participants will receive a single intravenous (IV) infusion of TAK-755 on Day 1 of Part A. All participants will be followed for up to 90 days post treatment.
• Experimental: Part B: TAK-755
  Participants will receive a single IV infusion of TAK-755 on Day 1 of Part B. All participants will be followed for up to 90 days post treatment.
• Placebo Comparator: Part A and B: Placebo
  Participants will receive a single IV infusion of TAK-755 matching placebo on Day 1 of Parts A and B. All participants will be followed for up to 90 days post treatment.

Primary Outcome Measure

Part A and B: Percentage of Participants who Develop Symptomatic Intracranial Hemorrhage (sICH) as Defined by the Heidelberg Bleeding Classification System [ Time Frame: Up to 120 hours of study drug administration ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (9)

Find similar trials in Scottsdale, AZ

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