Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief summary
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 \[EOT\]).
Interventions
BIOLOGICALTAK-881
TAK-881 SC injection.
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 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
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 coronavirus disease 2019 \[COVID-19\] vaccines) during the last 30 days before dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Tolerable Infusions of TAK-881 | From start of the study drug administration up to Day 57 | 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. |
| Number of Tolerable Infusions | From start of the study drug administration up to Day 57 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Sign Values | Up to Week 16 | 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. |
| Number of Participants With TEAEs | From start of the study drug administration up to Week 16 | 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. |
| Number of Participants With Neutralizing Antibodies to rHuPH20 | 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 Clinically Significant Changes in Clinical Laboratory Values | Up to Week 16 | Laboratory parameters will include serum chemistry, hematology, coagulation and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion. |
Countries
United States
Outcome results
None listed