TAK-881 and HyQvia for Healthy Adults

Overseen By Takeda Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must not be taking: Biologics, Vaccines, others

Disqualifiers: Blood disorders, Liver, Heart, others

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

Compensation: Varies

Number of Visits: 17

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body handles two treatments, TAK-881 and HyQvia (an immune globulin infusion), after a single injection under the skin. The main focus is on understanding how the body absorbs, processes, and removes these treatments. Participants will receive one of the treatments and stay at the clinic for a week, followed by several follow-up visits. Ideal candidates are healthy non-smokers with a stable body weight and no major medical conditions. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive a 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 is generally well-tolerated. Ongoing studies are examining its long-term safety for individuals with primary immunodeficiency diseases (PIDD). Although specific side effects are not detailed, the focus on long-term use ensures careful safety evaluation.

For HyQvia, studies indicate that most injection site side effects are mild to moderate and typically resolve within a few hours. HyQvia has been used to treat conditions such as PIDD and chronic inflammatory demyelinating polyneuropathy (CIDP) and is generally well-tolerated.

Both treatments have safety data suggesting they are well-tolerated, but this trial is in its early stages. The trial aims to understand how the body responds to these treatments. Participants will be closely monitored to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because TAK-881 and HyQvia offer innovative approaches to immune system support. HyQvia is unique because it combines immune globulin with recombinant human hyaluronidase, which helps the body absorb the medication more effectively and potentially allows for less frequent dosing compared to standard immune globulin treatments. TAK-881 stands out for its subcutaneous delivery using investigational needle sets, which could improve patient comfort and convenience compared to traditional intravenous methods. These features might offer enhanced patient experience and adherence, marking a significant advancement in treatment options.

What evidence suggests that this trial's treatments could be effective?

This trial will compare TAK-881 and HyQvia, both given as single subcutaneous injections. Research has shown that HyQvia effectively treats chronic inflammatory demyelinating polyneuropathy (CIDP) by preventing the recurrence of nerve problems. Long-term studies have confirmed its safety and effectiveness, indicating it can be used for up to 77 months. For TAK-881, research primarily focuses on its pharmacokinetics and safety. The goal is to ensure it is well tolerated, although specific effectiveness results are not yet available. Overall, HyQvia has more evidence supporting its benefits, particularly for nerve-related conditions. ^{6 7 8 9 10}

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 stay at the clinic for 8 days and commit to follow-up visits until Day 85. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Must be medically healthy

Must follow protocol-specified contraception guidance

Must be a non-smoker, with no use of nicotine or tobacco products

Exclusion Criteria

Pregnant or breastfeeding

Recently donated blood or blood products

History of alcohol or drug abuse within 2 years before dosing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of TAK-881 or HyQvia on Day 1

1 day

1 visit (in-person)

In-clinic Observation

Participants stay at the clinic for observation after receiving the dose

8 days

8 days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

77 days

8 visits (ambulatory)

What Are the Treatments Tested in This Trial?

Interventions

• HyQvia
• TAK-881

Trial Overview The study is testing how TAK-881 and HyQvia are absorbed and processed by the body when given as a single under-the-skin injection. Participants will receive one dose on Day 1 and be monitored over an extended period.

How Is the Trial Designed?

Group I: TAK-881 1.0 g/kg Experimental Treatment 2 Interventions

Participants will receive TAK-881, 1.0 gram per Kilogram (g/kg), single subcutaneous (SC) injection using investigational needle sets on Day 1.

Group II: HyQvia 1g/kg Experimental Treatment 2 Interventions

Participants will receive HyQvia, 1.0 g/kg, single SC injection using investigational needle sets on Day 1.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7140738/

Clinical Practice Experience with HyQvia in Adults Using ... This retrospective study was designed to evaluate the clinical experience of treating patients with PID with HyQvia regimens outside of package insert ...

2. hyqviahcp.com hyqviahcp.com/cidp/efficacy

ADVANCE-1 & 3 Study Data for HCPs - HyQvia HyQvia is indicated for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular ...

3. 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.

4. fda.gov fda.gov/media/168254/download

April 7, 2023 Statistical Review Memo - HYQVIA A total of 13/66 subjects had anti-rHuPH20 antibody titers ≥1:160 in. Study 160902. I verified the efficacy results that appear in the proposed ...

5. takeda.com takeda.com/newsroom/newsreleases/2024/takeda-presents-long-term-data-from-phase-3-advance-cidp-3-clinical-trial-of-hyqvia/

Takeda Presents Long-Term Data from ADVANCE-CIDP 3 ... The primary outcome measure was safety/tolerability and immunogenicity. The median duration of HYQVIA treatment was 33 months (0 to 77 months) ...

6. hyqviahcp.com hyqviahcp.com/primary-immunodeficiency/safety

HYQVIA Safety | Official Healthcare Professional Site Discover safety data for HYQVIA [Ig Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution. See Safety Info & Thrombosis Warning in Full

7. hyqvia.com hyqvia.com/primary-immunodeficiency/effectiveness-and-safety

HyQvia Side Effects & Safety Considerations 99% of side effects at the infusion site, or local side effects, were considered mild to moderate. These side effects generally go away in a few hours.

8. hyqviahcp.com hyqviahcp.com/cidp/safety

HyQvia Safety in CIDP | ADVANCE-1 & 3 Study Data for HCPs Explore HyQvia safety information and review side effects. See Important Safety Info & Thrombosis Warning in Full Prescribing Info.

9. fda.gov fda.gov/media/168253/download

April 7, 2023 Clinical Review Memo - HYQVIA There was a mean rate of 0.04 (upper 99% CI 0.21) serious bacterial infections per subject-year. The study met its primary efficacy endpoint. To ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT02556775

Pregnancy Registry to Collect Long-Term Safety Data From ... The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20 antibodies), regarding the course and outcome of pregnancy in ...