Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2025-03-24
2025-07-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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TAK-881 1.0 g/kg
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
Participants will receive SC infusion of TAK-881.
SC Investigational Needle Sets
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.
HyQvia 1g/kg
Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1.
HyQvia
Participants will receive SC infusion of HyQvia.
SC Investigational Needle Sets
The single-use only SC needle set will be used to administer HyQvia to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.
Interventions
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TAK-881
Participants will receive SC infusion of TAK-881.
HyQvia
Participants will receive SC infusion of HyQvia.
SC Investigational Needle Sets
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.
SC Investigational Needle Sets
The single-use only SC needle set will be used to administer HyQvia to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Celerion
Tempe, Arizona, United States
Countries
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Related Links
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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.
Other Identifiers
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TAK-881-1002
Identifier Type: -
Identifier Source: org_study_id
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