COMPLETED

A Study of TAK-881 and HyQvia in Healthy Adults

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-24
Study Completion:2025-07-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06895967

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.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men and Women between 18 and 50 years can participate.
  2. 2. Must be a non-smoker, with no use of nicotine or tobacco products.
  3. 3. Must have Body Mass Index (BMI) between 18.0 and 30.0, and body weight under 120 kilograms (kg).
  4. 4. Must be medically healthy.
  5. 5. Must follow protocol-specified contraception guidance.
  1. 1. Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition.
  2. 2. History of alcohol or drug abuse within 2 years before dosing.
  3. 3. History or presence of hypersensitivity or severe allergic reactions to blood or blood components.
  4. 4. History or presence of thrombotic/thromboembolic events, or venous thrombosis.
  5. 5. Pregnant or breastfeeding.
  6. 6. Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements.
  7. 7. Recently donated blood or blood products.
  8. 8. Participated in another clinical trial involving immunoglobulin products within 12 months of screening.
  9. 9. Has taken biologic agents within 12 weeks of screening.
  10. 10. Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
  11. 11. Has received any vaccine (including live attenuated vaccines and COVID-19 vaccines) during the last 30 days before dosing.

Contacts and Locations

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

Celerion
Tempe, Arizona, 85283
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-24
Study Completion Date2025-07-24

Study Record Updates

Study Start Date2025-03-24
Study Completion Date2025-07-24

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy

Additional Relevant MeSH Terms

  • Healthy Volunteers