A Study of TAK-881 and HyQvia in Healthy Adults

Description

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.

Conditions

Healthy Volunteers

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Study Overview

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Study Details

Study overview

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.

A Phase 1, Randomized, Open-Label, Pharmacokinetic Trial of TAK-881 and HyQvia in Healthy Adults

A Study of TAK-881 and HyQvia in Healthy Adults

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Tempe

Celerion, Tempe, Arizona, United States, 85283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Takeda,

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

2025-07-24