Status:
COMPLETED
A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
Lead Sponsor:
Takeda
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06935266
Start Date
April 22 2025
End Date
September 22 2025
Last Update
November 3 2025
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283