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

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Biological: TAK-881; Device: SC Investigational Needle Sets

• Registration Number: NCT06935266
• Lead Sponsor: Takeda

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 \[EOT\]).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-11
• Study First Posted: 2025-04-20
• Study Start: 2025-04-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-10-21
• Study Completion: 2025-10-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1, Schedule B, Treatment Arm 1: TAK-881	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.
Cohort 1, Schedule B, Treatment Arm 1: TAK-881	SC Investigational Needle Sets	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	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.
Cohort 1, Schedule C, Treatment Arm 2: TAK-881	SC Investigational Needle Sets	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	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.
Cohort 2, Schedule A, Treatment Arm 3: TAK-881	SC Investigational Needle Sets	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	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.
Cohort 2, Schedule B: Treatment Arm 4: TAK-881	SC Investigational Needle Sets	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.
Cohort 2, Schedule C: Treatment Arm 5: TAK-881	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.
Cohort 3, Schedule B: Treatment Arm 7: TAK-881	SC Investigational Needle Sets	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 2, Schedule C: Treatment Arm 5: TAK-881	SC Investigational Needle Sets	Participants will receive TAK-881, SC injection, 1.0 g/kg on Days 1, 29 and 57 in no ramp-up dosing manner.
Cohort 3, Schedule A: Treatment Arm 6: TAK-881	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.
Cohort 3, Schedule A: Treatment Arm 6: TAK-881	SC Investigational Needle Sets	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	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.
Cohort 3, Schedule C: Treatment Arm 8: TAK-881	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.
Cohort 3, Schedule C: Treatment Arm 8: TAK-881	SC Investigational Needle Sets	Participants will receive TAK-881, SC injection, 2.0 g/kg, on Days 1, 29 and 57 in no ramp-up dosing manner.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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.
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.

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States