A Study of TAK-881 and HyQvia in Healthy Adults

Launched by TAKEDA · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two medications, TAK-881 and HyQvia, to see how the body absorbs and processes them after they are given as a single injection under the skin. The main goal is to learn more about how these medications work in healthy adults. If you participate, you will receive one of these medications on the first day of the study and will need to stay at the clinic for 8 days. After that, there will be additional follow-up visits up to 85 days after your injection.

To be eligible for this study, you need to be a healthy adult between the ages of 18 and 50, a non-smoker, and have a body weight of less than 120 kilograms. You should not have any significant medical conditions or a history of substance abuse. Participants will need to follow specific guidelines regarding contraception and may be asked to avoid certain medications during the study. This trial is not yet recruiting, so there's no need to apply just yet, but it’s important to know that participation could help researchers better understand these medications in the future.

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.
• • 3. Must have Body Mass Index (BMI) between 18.0 and 30.0, and body weight under 120 kilograms (kg).
• • 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 COVID-19 vaccines) during the last 30 days before dosing.