A Study of TAK-881 and HyQvia in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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 in healthy adults. Study participants will receive a single dose of TAK-881 or HyQvia on Day 1. During the study, participants will need to stay at the clinic for 8 days followed by 8 ambulatory follow up visits till Day 85.

Key facts

Study ID

NCT06895967

Run by

Takeda

People needed

30

Starts

2025-03-24

Expected to finish

2025-08-08

Last updated by the study team

2026-06-11

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.
• 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.

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 COVID-19 vaccines) during the last 30 days before dosing.

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.