TAK-881 for Healthy Adults

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must not be taking: Biologics, Vaccines, Investigational products, others

Disqualifiers: Blood/clotting disorder, Liver, Heart, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how well healthy adults can tolerate a new treatment called TAK-881, administered as an infusion under the skin. Researchers will test different dosing schedules to observe how the body processes this treatment over time. Healthy adults who do not smoke and have no major health issues, such as heart or liver problems, may qualify for this study. Participants will not take any other medications or supplements during the trial period. As a Phase 1 trial, this research focuses on understanding how TAK-881 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TAK-881 has been tested before and is generally safe for people. In earlier studies, most participants experienced only mild side effects. Common side effects included minor skin reactions at the injection site, such as redness or swelling, which were not serious and resolved on their own.

Since TAK-881 remains in early testing, this study will provide more insight into how the body processes the drug at different doses. As the study is in its early phase, it primarily focuses on assessing the drug's safety and tolerability.

Overall, while some evidence suggests TAK-881 is safe, this study will offer more detailed information about its safety in healthy adults.

Why are researchers excited about this trial's treatment?

Researchers are excited about TAK-881 because it offers a unique approach compared to existing treatments for the condition in question. Unlike many standard options that involve oral administration or intravenous infusions, TAK-881 is delivered through a subcutaneous injection, which can be more convenient and potentially less invasive for patients. Moreover, the treatment features a flexible dosing regimen, including both ramp-up and non-ramp-up schedules, allowing for tailored dosing strategies that might optimize efficacy and minimize side effects. These innovative aspects could make TAK-881 a promising alternative to traditional therapies.

What evidence suggests that TAK-881 could be effective for healthy adults?

Research has shown that TAK-881, a special protein in the blood, helps fight infections and is combined with an enzyme to enhance absorption. Previous patients demonstrated that the body can absorb and process this treatment well. Early studies examined the tolerance of TAK-881 when administered subcutaneously in varying doses. In this trial, participants will receive TAK-881 in various dosing regimens across different treatment arms to ensure it works safely and effectively without causing unwanted reactions. More data is needed to confirm its effectiveness, but the treatment shows promise based on its absorption. ^{1 2 3 4 5}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study lasting about 19 weeks. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conditions that would interfere with the study.

Inclusion Criteria

Must follow protocol-specified contraception guidance

Must have Body Mass Index (BMI) between 18.0 and 30.0 kilograms per square meter (kg/m^2)

I haven't smoked or used nicotine products for at least 3 months.

Exclusion Criteria

History of alcohol or drug abuse within 2 years before dosing

History or presence of hypersensitivity or severe allergic reactions to blood or blood components

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TAK-881 subcutaneous infusions with varying dosing schedules

8 weeks

Multiple visits for infusions on Days 1, 8, 15, 22, 29, 50, and 57

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TAK-881

Trial Overview The trial is testing TAK-881, which will be administered through subcutaneous infusions. Participants will first receive a lower dose on Day 1, followed by multiple infusions at higher doses to evaluate tolerability of different dosing schedules.

How Is the Trial Designed?

Group I: Cohort 3, Schedule C: Treatment Arm 8: TAK-881 Experimental Treatment 2 Interventions

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

Group II: Cohort 3, Schedule B: Treatment Arm 7: TAK-881 Experimental Treatment 2 Interventions

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.

Group III: Cohort 3, Schedule A: Treatment Arm 6: TAK-881 Experimental Treatment 2 Interventions

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.

Group IV: Cohort 2, Schedule C: Treatment Arm 5: TAK-881 Experimental Treatment 2 Interventions

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

Group V: Cohort 2, Schedule B: Treatment Arm 4: TAK-881 Experimental Treatment 2 Interventions

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.

Group VI: Cohort 2, Schedule A, Treatment Arm 3: TAK-881 Experimental Treatment 2 Interventions

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.

Group VII: Cohort 1, Schedule C, Treatment Arm 2: TAK-881 Experimental Treatment 2 Interventions

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

Group VIII: Cohort 1, Schedule B, Treatment Arm 1: TAK-881 Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06935266

A Study of TAK-881 With and Without Ramp-Up Dosing in ... The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10739571/

A Phase 1 Open-Label Study to Assess the Tolerability ... Hyaluronidase-facilitated subcutaneous immunoglobulin 20% (fSCIG 20%, also known as TAK-881) is an infusion of IgG 20% and rHuPH20. The ...

3. clinicaltrials.takeda.com clinicaltrials.takeda.com/study-detail/93ce00d8c19e4041?idFilter=%5B%22TAK-881-3001

TAK-881-3001 | Clinical Trial Summary The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06895967

A Study of TAK-881 and HyQvia in Healthy Adults The main aim of this study is to understand how the body absorbs, processes, and removes (known as pharmacokinetics or PK) TAK-881 and HyQvia.

5. trialx.com trialx.com/clinical-trials/listings/251782/a-study-about-how-tak-881-is-processed-by-the-body-and-side-effects-in-people-with-primary-immunodeficiency-diseases/?&geo_lat=40.4842027&geo_lng=-88.9936873&radius=10&place=Bloomington&user_country=United%20States

A Study About How TAK-881 is Processed by the Body and ... The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in ...