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

Launched by TAKEDA · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called TAK-881 to see how well healthy adults can tolerate it when given in different doses. The study will start with a lower dose of TAK-881 injected just under the skin on the first day, then participants will receive higher doses during the trial. The entire study will last about 19 weeks, including time for initial checks and follow-up after the treatment ends.

To participate, you need to be a healthy adult between 18 and 50 years old, a non-smoker, and have a body mass index (BMI) between 18.0 and 30.0. It's important that you don't have any significant medical issues, such as heart or lung problems, and you should not be pregnant or breastfeeding. Participants will need to follow specific guidelines regarding medications and health conditions. If you decide to take part, you will help researchers understand how TAK-881 works and its effects on the body.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men and Women between 18 and 50 years can participate.
• • 2. Must be a non-smoker, with no use of nicotine or tobacco products for at least 3 months prior to the first dosing.
• • 3. Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m\^2).
• • 4. Must be medically healthy.
• • 5. Must follow protocol-specified contraception guidance.
• Exclusion Criteria:
• • 1. Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition.
• • 2. History of alcohol or drug abuse within 2 years before dosing.
• • 3. History or presence of hypersensitivity or severe allergic reactions to blood or blood components.
• • 4. History or presence of thrombotic/thromboembolic events, or venous thrombosis.
• • 5. Pregnant or breastfeeding.
• • 6. Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements.
• • 7. Recently donated blood or blood products.
• • 8. Participated in another clinical trial involving immunoglobulin products within 12 months of screening.
• • 9. Has taken biologic agents within 12 weeks of screening.
• • 10. Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
• • 11. Has received any vaccine (including live attenuated vaccines and coronavirus disease 2019 \[COVID-19\] vaccines) during the last 30 days before dosing.