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The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, Schedule B, Treatment Arm 1: TAK-881 | Experimental | 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. |
|
| Cohort 1, Schedule C, Treatment Arm 2: TAK-881 | Experimental | Participants will receive TAK-881, SC injection, 0.6 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner. |
|
| Cohort 2, Schedule A, Treatment Arm 3: TAK-881 | Experimental | 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. |
|
| Cohort 2, Schedule B: Treatment Arm 4: TAK-881 | Experimental | 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. |
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| Cohort 2, Schedule C: Treatment Arm 5: TAK-881 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-881 | Biological | TAK-881 SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Tolerable Infusions of TAK-881 | A tolerable infusion is considered to have occurred if an infusion is completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any treatment-emergent adverse events (TEAEs) related to TAK-881. | From start of the study drug administration up to Day 57 |
| Number of Tolerable Infusions | A tolerable infusion is considered to have occurred if an infusion is completed without interruption (discontinuing the infusion, or infusion rate reduction) due to any TEAEs related to TAK-881. | From start of the study drug administration up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With TEAEs | TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. | From start of the study drug administration up to Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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Participants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner. |
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| Cohort 3, Schedule A: Treatment Arm 6: TAK-881 | Experimental | 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. |
|
| Cohort 3, Schedule B: Treatment Arm 7: TAK-881 | Experimental | 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. |
|
| Cohort 3, Schedule C: Treatment Arm 8: TAK-881 | Experimental | Participants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner. |
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| SC Investigational Needle Sets | Device | 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. |
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| Number of Participants With Clinically Significant Changes in Clinical Laboratory Values | Laboratory parameters will include serum chemistry, hematology, coagulation and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion. | Up to Week 16 |
| Number of Participants With Clinically Significant Changes in Vital Sign Values | Vital signs will include measurement of heart rate/ pulse rate, systolic, diastolic blood pressure, body temperature and respiratory rate. Clinical significance of vital signs will be determined at the investigator's discretion. | Up to Week 16 |
| Number of Participants With Positive Binding Antibodies (Titer Greater Than or Equal to [>=] 1:160) | Up to Week 16 |
| Number of Participants With Neutralizing Antibodies to rHuPH20 | Up to Week 16 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004364 | Pharmaceutical Preparations |