A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
NCT ID: NCT06935266
Last Updated: 2025-11-03
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
64 participants
INTERVENTIONAL
2025-04-22
2025-09-22
Brief Summary
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During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous \[SC\] infusion) on Day 1 at a lower dose level followed by participants receiving multiple infusion of higher dose levels.
Participants will be in the study for approximately 19 weeks including screening period and follow-up (End of Treatment \[EOT\]).
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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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Cohort 1, Schedule B, Treatment Arm 1: TAK-881
Participants will receive TAK-881, subcutaneous (SC) injection, 0.15 grams per kilogram (g/kg) on Day 1, 0.3 g/kg on Day 8, 0.6 g/kg on Days 22 and 50 in ramp-up dosing manner.
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.
TAK-881
TAK-881 SC injection.
Cohort 1, Schedule C, Treatment Arm 2: TAK-881
Participants will receive TAK-881, SC injection, 0.6 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.
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.
TAK-881
TAK-881 SC injection.
Cohort 2, Schedule A, Treatment Arm 3: TAK-881
Participants will receive TAK-881, SC injection, 0.25 g/kg on Days 1 and 8, 0.5 g/kg on Day 15, 0.75 g/kg on Day 29 and 1.0 g/kg on Day 50 in ramp-up dosing manner.
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.
TAK-881
TAK-881 SC injection.
Cohort 2, Schedule B: Treatment Arm 4: TAK-881
Participants will receive TAK-881, SC injection, 0.25 g/kg on Day 1, 0.5 g/kg on Day 8, 1.0 g/kg on Days 22 and 50 in ramp-up dosing manner.
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.
TAK-881
TAK-881 SC injection.
Cohort 2, Schedule C: Treatment Arm 5: TAK-881
Participants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.
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.
TAK-881
TAK-881 SC injection.
Cohort 3, Schedule A: Treatment Arm 6: TAK-881
Participants will receive TAK-881, SC injection, 0.5 g/kg on Days 1 and 8, 1.0 g/kg on Day 15, 1.5 g/kg on Day 29 and 2.0 g/kg on Day 50 in ramp-up dosing manner.
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.
TAK-881
TAK-881 SC injection.
Cohort 3, Schedule B: Treatment Arm 7: TAK-881
Participants will receive TAK-881, SC injection, 0.5 g/kg on Day 1, 1.0 g/kg on Day 8, 2.0 g/kg on Days 22 and 50 in ramp-up dosing manner.
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.
TAK-881
TAK-881 SC injection.
Cohort 3, Schedule C: Treatment Arm 8: TAK-881
Participants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner.
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.
TAK-881
TAK-881 SC injection.
Interventions
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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.
TAK-881
TAK-881 SC injection.
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 for at least 3 months prior to the first dosing.
3. Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m\^2).
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 coronavirus disease 2019 \[COVID-19\] 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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To obtain more information on the study, click here/on this link
Other Identifiers
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TAK-881-1003
Identifier Type: -
Identifier Source: org_study_id
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