Status:
COMPLETED
A Study of TAK-881 and HyQvia 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 understand how the body absorbs, processes, and removes (known as pharmacokinetics or PK) TAK-881 and HyQvia, after they are given as a single injection 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.
- Must have Body Mass Index (BMI) between 18.0 and 30.0, and body weight under 120 kilograms (kg).
- 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 COVID-19 vaccines) during the last 30 days before dosing.
Key Trial Info
Start Date :
March 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06895967
Start Date
March 24 2025
End Date
July 24 2025
Last Update
August 19 2025
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283