A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults

Takeda

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: TAK-881; Device: SC Investigational Needle Sets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06935266

TAK-881-1003

Details and patient eligibility

About

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]).

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 8 patient groups

Cohort 1, Schedule B, Treatment Arm 1: TAK-881

Experimental group

Description:

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.

Treatment:

Device: SC Investigational Needle Sets

Biological: TAK-881

Cohort 1, Schedule C, Treatment Arm 2: TAK-881

Experimental group

Description:

Participants will receive TAK-881, SC injection, 0.6 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.

Treatment:

Device: SC Investigational Needle Sets

Biological: TAK-881

Cohort 2, Schedule A, Treatment Arm 3: TAK-881

Experimental group

Description:

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.

Treatment:

Device: SC Investigational Needle Sets

Biological: TAK-881

Cohort 2, Schedule B: Treatment Arm 4: TAK-881

Experimental group

Description:

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.

Treatment:

Device: SC Investigational Needle Sets

Biological: TAK-881

Cohort 2, Schedule C: Treatment Arm 5: TAK-881

Experimental group

Description:

Participants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.

Treatment:

Device: SC Investigational Needle Sets

Biological: TAK-881

Cohort 3, Schedule A: Treatment Arm 6: TAK-881

Experimental group

Description:

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.

Treatment:

Device: SC Investigational Needle Sets

Biological: TAK-881

Cohort 3, Schedule B: Treatment Arm 7: TAK-881

Experimental group

Description:

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.

Treatment:

Device: SC Investigational Needle Sets

Biological: TAK-881

Cohort 3, Schedule C: Treatment Arm 8: TAK-881

Experimental group

Description:

Participants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner.

Treatment:

Device: SC Investigational Needle Sets

Biological: TAK-881