A Study of TAK-881 and HyQvia in Healthy Adults

NCT06895967 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: TAK-881-1002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day1-29) Based on Serum Total Immunoglobulin G (IgG) Levels

  Day 1 up to Day 29

Secondary Outcomes (15)

• Baseline-Uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels

  From Screening up to Day 85

• Baseline-Uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels

  From Screening up to Day 85

• Baseline-Uncorrected AUC Day1-29 Based on Serum Total IgG Levels

  Day 1 up to Day 29

• Baseline-corrected AUC from Day 1 to infinity (AUCinf) Based on Serum Total IgG Levels

  From Day 1 up to Day 85

• Baseline-corrected AUC from Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels

  From Day 1 up to Day 85

Study Arms (2)

TAK-881 1.0 g/kg

EXPERIMENTAL

Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1.

Biological: TAK-881; Device: SC Investigational Needle Sets

HyQvia 1g/kg

EXPERIMENTAL

Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1.

Biological: HyQvia; Device: SC Investigational Needle Sets

Interventions

TAK-881 BIOLOGICAL

Participants will receive SC infusion of TAK-881.

Also known as: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)

TAK-881 1.0 g/kg

HyQvia BIOLOGICAL

Participants will receive SC infusion of HyQvia.

Also known as: Immune Globulin Subcutaneous (Human), 10% Solution with rHuPH20

HyQvia 1g/kg

SC Investigational Needle Sets DEVICE

The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.

TAK-881 1.0 g/kg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Interventions

gamma-Globulins; Solutions

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pharmaceutical Preparations

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: March 24, 2025
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)