A Study of TAK-881 and HyQvia in Healthy Adults

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Biological: TAK-881; Biological: HyQvia; Device: SC Investigational Needle Sets

• Registration Number: NCT06895967
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Study Start: 2025-03-24
• Study First Posted: 2025-03-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-07-24
• Study Completion: 2025-07-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Baseline-corrected Cmax Based on Serum Total IgG Levels	From Day 1 up to Day 85
Baseline-corrected Tmax Based on Serum Total IgG Levels	From Day 1 up to Day 85
Baseline-corrected Time of last measurable concentration (Tlast) Based on Serum Total IgG Levels	From Day 1 up to Day 85
Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels	From Day 1 up to Day 85
Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels	From Day 1 up to Day 85
Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels	From Day up to Day 85
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose of study drug up to Day 85	TEAEs are defined as AEs that started at or after the initiation of the first administration of TAK-881 or HyQvia or any adverse event already present that worsens in either intensity or frequency following exposure to TAK-881 or HyQvia.
Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions	From first dose of study drug up to Day 85
Number of Participants With Positive Binding Antibodies to rHuPH20	From first dose of study drug up to Day 85
Number of Participants With Neutralizing Antibodies to rHuPH20	From first dose of study drug up to Day 85

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States