Healthy Volunteers
Conditions
Keywords
Drug Therapy
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.
Interventions
BIOLOGICALTAK-881
Participants will receive SC infusion of TAK-881.
BIOLOGICALHyQvia
Participants will receive SC infusion of HyQvia.
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.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Time of last measurable concentration (Tlast) 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 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 | — |
| Baseline-corrected Terminal Half-life (t1/2z) Based on Serum Total IgG Levels | From Day 1 up to Day 85 | — |
Countries
United States
Outcome results
None listed