A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous \[SC\] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels. Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).

Key facts

Study ID

NCT06935266

Run by

Takeda

People needed

64

Starts

2025-04-22

Expected to finish

2025-09-22

Last updated by the study team

2025-11-03

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and Women between 18 and 50 years can participate.
• Must be a non-smoker, with no use of nicotine or tobacco products for at least 3 months prior to the first dosing.
• Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m\^2).
• Must be medically healthy.
• Must follow protocol-specified contraception guidance.

You may not qualify if…

• Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition.
• History of alcohol or drug abuse within 2 years before dosing.
• History or presence of hypersensitivity or severe allergic reactions to blood or blood components.
• History or presence of thrombotic/thromboembolic events, or venous thrombosis.
• Pregnant or breastfeeding.
• Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements.
• Recently donated blood or blood products.
• Participated in another clinical trial involving immunoglobulin products within 12 months of screening.
• Has taken biologic agents within 12 weeks of screening.
• Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
• Has received any vaccine (including live attenuated vaccines and coronavirus disease 2019 [COVID-19] vaccines) during the last 30 days before dosing.

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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