Phase 1
N=30
A Study of TAK-881 and HyQvia in Healthy Adults
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT06895967 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day 1-29) Based on Serum Total Immunoglobulin G (IgG) Levels — 2993; 3190 gram*hour per liter (g*h/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TAK-881 (Biological); HyQvia (Biological); SC Investigational Needle Sets (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline-corrected Area Under the Concentration-time Curve (AUC) From Day 1 to Day 29 (AUC Day 1-29) Based on Serum Total Immunoglobulin G (IgG) Levels |
2993; 3190 | — |
| SECONDARY Baseline-uncorrected Maximum Observed Concentration (Cmax) Based on Serum Total IgG Levels |
19.84; 20.70 | — |
| SECONDARY Baseline-uncorrected Time to Maximum Concentration (Tmax) Based on Serum Total IgG Levels |
167.741; 143.829 | — |
| SECONDARY Baseline-uncorrected AUC Day1-29 Based on Serum Total IgG Levels |
10310; 10720 | — |
| SECONDARY Baseline-corrected AUC From Day 1 to Infinity (AUCinf) Based on Serum Total IgG Levels |
4556; 5425 | — |
| SECONDARY Baseline-corrected AUC From Day 1 to Time of the Last Measurable Concentration (AUClast) Based on Serum Total IgG Levels |
4240; 4591 | — |
| SECONDARY Baseline-corrected Cmax Based on Serum Total IgG Levels |
8.875; 9.486 | — |
| SECONDARY Baseline-corrected Tmax Based on Serum Total IgG Levels |
167.741; 143.829 | — |
| SECONDARY Baseline-corrected Time of Last Measurable Concentration (Tlast) Based on Serum Total IgG Levels |
2015.748; 2015.705 | — |
| SECONDARY Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels |
146.613; 165.913 | — |
| SECONDARY Baseline-corrected Apparent Clearance (CL/F) Based on Serum Total IgG Levels |
0.01579; 0.01429 | — |
| SECONDARY Baseline-corrected Apparent Volume of Distribution (Vz/F) Based on Serum Total IgG Levels |
4.169; 3.823 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
15; 15 | — |
| SECONDARY Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions |
0; 0 | — |
| SECONDARY Number of Participants With Positive Binding Antibodies to rHuPH20 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Neutralizing Antibodies to rHuPH20 |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06895967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.